Vent adaptor for a respiratory therapy system

ABSTRACT

A vent adaptor for a for a respiratory pressure therapy (RPT) system, the vent adaptor comprising: a vent assembly comprising: a vent housing defining a central orifice for the flow of pressurized gas to pass through the vent assembly from the delivery conduit to the patient interface, the vent housing having an annular surface around the central orifice, and the annular surface having a plurality of holes to discharge pressurized gas to atmosphere; and a membrane positioned adjacent to the annular surface; a heat and moisture exchanger (HME); and a diffusing member.

1 CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/760,403, filed Mar. 15, 2018, now U.S. Pat. No. 10,773,044, which isthe U.S. national phase of International Application No.PCT/AU2016/050893, filed Sep. 23, 2016, which designated the U.S. andclaims the benefit of U.S. Provisional Application No. 62/222,604, filedon Sep. 23, 2015, the entire contents of each of which are herebyincorporated herein by reference.

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

2 BACKGROUND OF THE TECHNOLOGY 2.1 Field of the Technology

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. The present technology also relates to medical devices orapparatus, and their use.

2.2 Description of the Related Art

2.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2012.

A range of respiratory disorders exist. Certain disorders may becharacterised by particular events, e.g. apneas, hypopneas, andhyperpneas.

Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing(SDB), is characterized by events including occlusion or obstruction ofthe upper air passage during sleep. It results from a combination of anabnormally small upper airway and the normal loss of muscle tone in theregion of the tongue, soft palate and posterior oropharyngeal wallduring sleep. The condition causes the affected patient to stopbreathing for periods typically of 30 to 120 seconds in duration,sometimes 200 to 300 times per night. It often causes excessive daytimesomnolence, and it may cause cardiovascular disease and brain damage.The syndrome is a common disorder, particularly in middle agedoverweight males, although a person affected may have no awareness ofthe problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Cheyne-Stokes Respiration (CSR) is another form of sleep disorderedbreathing. CSR is a disorder of a patient's respiratory controller inwhich there are rhythmic alternating periods of waxing and waningventilation known as CSR cycles. CSR is characterised by repetitivede-oxygenation and re-oxygenation of the arterial blood. It is possiblethat CSR is harmful because of the repetitive hypoxia. In some patientsCSR is associated with repetitive arousal from sleep, which causessevere sleep disruption, increased sympathetic activity, and increasedafterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory Insufficiency is an umbrella term for respiratory disordersin which patients are unable to ventilate enough to balance the CO₂ intheir blood if their metabolic activity rises much above rest.Respiratory insufficiency may encompass some or all of the followingdisorders.

Obesity Hyperventilation Syndrome (OHS) is defined as the combination ofsevere obesity and awake chronic hypercapnia, in the absence of otherknown causes for hypoventilation. Symptoms include dyspnea, morningheadache and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a groupof lower airway diseases that have certain characteristics in common.These include increased resistance to air movement, extended expiratoryphase of respiration, and loss of the normal elasticity of the lung.Examples of COPD are emphysema and chronic bronchitis. COPD is caused bychronic tobacco smoking (primary risk factor), occupational exposures,air pollution and genetic factors. Symptoms include: dyspnea onexertion, chronic cough and sputum production.

Neuromuscular Disease (NMD) is a broad term that encompasses manydiseases and ailments that impair the functioning of the muscles eitherdirectly via intrinsic muscle pathology, or indirectly via nervepathology. Some NMD patients are characterised by progressive muscularimpairment leading to loss of ambulation, being wheelchair-bound,swallowing difficulties, respiratory muscle weakness and, eventually,death from respiratory failure. Neuromuscular disorders can be dividedinto rapidly progressive and slowly progressive: (i) Rapidly progressivedisorders: Characterised by muscle impairment that worsens over monthsand results in death within a few years (e.g. Amyotrophic lateralsclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers);(ii) Variable or slowly progressive disorders: Characterised by muscleimpairment that worsens over years and only mildly reduces lifeexpectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic musculardystrophy). Symptoms of respiratory failure in NMD include: increasinggeneralised weakness, dysphagia, dyspnea on exertion and at rest,fatigue, sleepiness, morning headache, and difficulties withconcentration and mood changes.

Chest wall disorders are a group of thoracic deformities that result ininefficient coupling between the respiratory muscles and the thoraciccage. The disorders are usually characterised by a restrictive defectand share the potential of long term hypercapnic respiratory failure.Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.Symptoms of respiratory failure include: dyspnea on exertion, peripheraloedema, orthopnea, repeated chest infections, morning headaches,fatigue, poor sleep quality and loss of appetite.

A range of therapies have been used to treat or ameliorate suchconditions. Furthermore, otherwise healthy individuals may takeadvantage of such therapies to prevent respiratory disorders fromarising. However, these have a number of shortcomings.

2.2.2 Therapy

Continuous Positive Airway Pressure (CPAP) therapy has been used totreat Obstructive Sleep Apnea (OSA). The mechanism of action is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion, such as by pushing the soft palate andtongue forward and away from the posterior oropharyngeal wall. Treatmentof OSA by CPAP therapy may be voluntary, and hence patients may electnot to comply with therapy if they find devices used to provide suchtherapy one or more of: uncomfortable, difficult to use, expensive andaesthetically unappealing.

Non-invasive ventilation (NIV) provides ventilatory support to a patientthrough the upper airways to assist the patient breathing and/ormaintain adequate oxygen levels in the body by doing some or all of thework of breathing. The ventilatory support is provided via anon-invasive patient interface. NIV has been used to treat CSR andrespiratory insufficiency, in forms such as OHS, COPD, MD and Chest Walldisorders. In some forms, the comfort and effectiveness of thesetherapies may be improved.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and may be providedusing a tracheostomy tube. In some forms, the comfort and effectivenessof these therapies may be improved.

2.2.3 Treatment Systems

These therapies may be provided by a treatment system or device. Suchsystems and devices may also be used to diagnose a condition withouttreating it.

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

Another form of treatment system is a mandibular repositioning device.

2.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment toits wearer, for example by providing a flow of air to an entrance to theairways. The flow of air may be provided via a mask to the nose and/ormouth, a tube to the mouth or a tracheostomy tube to the trachea of apatient. Depending upon the therapy to be applied, the patient interfacemay form a seal, e.g., with a region of the patient's face, tofacilitate the delivery of gas at a pressure at sufficient variance withambient pressure to effect therapy, e.g., at a positive pressure ofabout 10 cmH₂O relative to ambient pressure. For other forms of therapy,such as the delivery of oxygen, the patient interface may not include aseal sufficient to facilitate delivery to the airways of a supply of gasat a positive pressure of about 10 cmH₂O.

Certain other mask systems may be functionally unsuitable for thepresent field. For example, purely ornamental masks may be unable tomaintain a suitable pressure. Mask systems used underwater swimming ordiving may be configured to guard against ingress of water from anexternal higher pressure, but not to maintain air internally at a higherpressure than ambient.

Certain masks may be clinically unfavourable for the present technologye.g. if they block airflow via the nose and only allow it via the mouth.

Certain masks may be uncomfortable or impractical for the presenttechnology if they require a patient to insert a portion of a maskstructure in their mouth create and maintain a seal via their lips.

Certain masks may be impractical for use while sleeping, e.g. forsleeping while lying on one's side in bed with a head on a pillow.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesvaries considerably between individuals. Since the head includes bone,cartilage and soft tissue, different regions of the face responddifferently to mechanical forces. The jaw or mandible may move relativeto other bones of the skull. The whole head may move during the courseof a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use, and uncomfortable especially when worn for longperiods of time or when a patient is unfamiliar with a system. Forexample, masks designed solely for aviators, masks designed as part ofpersonal protection equipment (e.g. filter masks), SCUBA masks, or forthe administration of anaesthetics may be tolerable for their originalapplication, but nevertheless such masks may be undesirablyuncomfortable to be worn for extended periods of time, e.g., severalhours. This discomfort may lead to a reduction in patient compliancewith therapy. This is even more so if the mask is to be worn duringsleep.

CPAP therapy is highly effective to treat certain respiratory disorders,provided patients comply with therapy. If a mask is uncomfortable, ordifficult to use a patient may not comply with therapy. Since it isoften recommended that a patient regularly wash their mask, if a mask isdifficult to clean (e.g., difficult to assemble or disassemble),patients may not clean their mask and this may impact on patientcompliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, patient interfaces for delivery of CPAP during sleepform a distinct field.

2.2.3.1.1 Seal-Forming Portion

Patient interfaces may include a seal-forming portion. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming portion can have a direct impact the effectiveness andcomfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming portion is to engage with the face inuse. In one form of patient interface, a seal-forming portion maycomprise two sub-portions to engage with respective left and rightnares. In one form of patient interface, a seal-forming portion maycomprise a single element that surrounds both nares in use. Such singleelement may be designed to for example overlay an upper lip region and anasal bridge region of a face. In one form of patient interface aseal-forming portion may comprise an element that surrounds a mouthregion in use, e.g. by forming a seal on a lower lip region of a face.In one form of patient interface, a seal-forming portion may comprise asingle element that surrounds both nares and a mouth region in use.These different types of patient interfaces may be known by a variety ofnames by their manufacturer including nasal masks, full-face masks,nasal pillows, nasal puffs and oro-nasal masks.

A seal-forming portion that may be effective in one region of apatient's face may be inappropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming portions may be designed for mass manufacture suchthat one design fit and be comfortable and effective for a wide range ofdifferent face shapes and sizes. To the extent to which there is amismatch between the shape of the patient's face, and the seal-formingportion of the mass-manufactured patient interface, one or both mustadapt in order for a seal to form.

One type of seal-forming portion extends around the periphery of thepatient interface, and is intended to seal against the patient's facewhen force is applied to the patient interface with the seal-formingportion in confronting engagement with the patient's face. Theseal-forming portion may include an air or fluid filled cushion, or amoulded or formed surface of a resilient seal element made of anelastomer such as a rubber. With this type of seal-forming portion, ifthe fit is not adequate, there will be gaps between the seal-formingportion and the face, and additional force will be required to force thepatient interface against the face in order to achieve a seal.

Another type of seal-forming portion incorporates a flap seal of thinmaterial positioned about the periphery of the mask so as to provide aself-sealing action against the face of the patient when positivepressure is applied within the mask. Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to achieve a seal, or the mask mayleak. Furthermore, if the shape of the seal-forming portion does notmatch that of the patient, it may crease or buckle in use, giving riseto leaks.

Another type of seal-forming portion may comprise a friction-fitelement, e.g. for insertion into a naris, however some patients findthese uncomfortable.

Another form of seal-forming portion may use adhesive to achieve a seal.Some patients may find it inconvenient to constantly apply and remove anadhesive to their face.

A range of patient interface seal-forming portion technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask,SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGELIBERTY™ full-face mask. The following patent applications, assigned toResMed Limited, describe examples of nasal pillows masks: InternationalPatent Application WO2004/073,778 (describing amongst other thingsaspects of the ResMed Limited SWIFT™ nasal pillows), US PatentApplication 2009/0044808 (describing amongst other things aspects of theResMed Limited SWIFT™ LT nasal pillows); International PatentApplications WO 2005/063,328 and WO 2006/130,903 (describing amongstother things aspects of the ResMed Limited MIRAGE LIBERTY™ full-facemask); International Patent Application WO 2009/052,560 (describingamongst other things aspects of the ResMed Limited SWIFT™ FX nasalpillows).

2.2.3.1.2 Positioning and Stabilising

A seal-forming portion of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming portion, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US PatentApplication Publication No. US 2010/0000534. However, the use ofadhesives may be uncomfortable for some.

Another technique is the use of one or more straps and/or stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

2.2.3.1.3 Vent Technologies

Some forms of patient interface systems may include a vent to allow thewashout of exhaled carbon dioxide. The vent may allow a flow of gas froman interior space of the patient interface, e.g., the plenum chamber, toan exterior of the patient interface, e.g., to ambient. The vent maycomprise an orifice and gas may flow through the orifice in use of themask. Many such vents are noisy. Others may become blocked in use andthus provide insufficient washout. Some vents may be disruptive of thesleep of a bed partner 1100 of the patient 1000, e.g. through noise orfocussed airflow.

ResMed Limited has developed a number of improved mask venttechnologies. See International Patent Application Publication No. WO1998/034,665; International Patent Application Publication No. WO2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application PublicationNo. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

Table of noise of prior masks (ISO 17510-2:2007, 10 cmH₂O pressure at 1m)

A-weighted A-weighted sound power sound pressure Mask level dB(A) dB(A)Year Mask name type (uncertainty) (uncertainty) (approx.) Glue-on (*)nasal 50.9 42.9 1981 ResCare nasal 31.5 23.5 1993 standard (*) ResMednasal 29.5 21.5 1998 Mirage ™ (*) ResMed nasal 36 (3) 28 (3) 2000UltraMirage ™ ResMed nasal 32 (3) 24 (3) 2002 Mirage Activa ™ ResMednasal 30 (3) 22 (3) 2008 Mirage Micro ™ ResMed nasal 29 (3) 22 (3) 2008Mirage ™ SoftGel ResMed nasal 26 (3) 18 (3) 2010 Mirage ™ FX ResMednasal 37   29   2004 Mirage Swift ™ pillows (*) ResMed nasal 28 (3) 20(3) 2005 Mirage Swift ™ pillows II ResMed nasal 25 (3) 17 (3) 2008Mirage Swift ™ pillows LT ResMed AirFit nasal 21 (3) 13 (3) 2014 P10pillows (* one specimen only, measured using test method specified inISO 3744 in CPAP mode at 10 cmH₂O)Sound pressure values of a variety ofobjects are listed below A-weighted sound Object pressure dB(A) NotesVacuum cleaner: Nilfisk 68 ISO 3744 at Walter Broadly Litter Hog: B+ 1 mdistance Grade Conversational speech 60 1 m distance Average home 50Quiet library 40 Quiet bedroom at night 30 Background in TV studio 202.2.3.2 Respiratory Pressure Therapy (RPT) Device

Air pressure generators are known in a range of applications, e.g.industrial-scale ventilation systems. However, air pressure generatorsfor medical applications have particular requirements not fulfilled bymore generalised air pressure generators, such as the reliability, sizeand weight requirements of medical devices. In addition, even devicesdesigned for medical treatment may suffer from shortcomings, pertainingto one or more of: comfort, noise, ease of use, efficacy, size, weight,manufacturability, cost, and reliability.

An example of the special requirements of certain RPT devices isacoustic noise.

Table of noise output levels of prior RPT devices (one specimen only,measured using test method specified in ISO 3744 in CPAP mode at 10cmH₂O).

A-weighted sound power Year RPT Device name level dB(A) (approx.)C-Series Tango ™ 31.9 2007 C-Series Tango ™ with Humidifier 33.1 2007 S8Escape ™ II 30.5 2005 S8 Escape ™ II with H4i ™ Humidifier 31.1 2005 S9AutoSet ™ 26.5 2010 S9 AutoSet ™ with H5i Humidifier 28.6 2010

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed Limited. Another exampleof an RPT device is a ventilator. Ventilators such as the ResMedStellar™ Series of Adult and Paediatric Ventilators may provide supportfor invasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit. RPT devicestypically comprise a pressure generator, such as a motor-driven bloweror a compressed gas reservoir, and are configured to supply a flow ofair to the airway of a patient. In some cases, the flow of air may besupplied to the airway of the patient at positive pressure. The outletof the RPT device is connected via an air circuit to a patient interfacesuch as those described above.

The designer of a device may be presented with an infinite number ofchoices to make. Design criteria often conflict, meaning that certaindesign choices are far from routine or inevitable. Furthermore, thecomfort and efficacy of certain aspects may be highly sensitive tosmall, subtle changes in one or more parameters.

2.2.3.3 Humidifier

Delivery of a flow of air without humidification may cause drying ofairways. The use of a humidifier with an RPT device and the patientinterface produces humidified gas that minimizes drying of the nasalmucosa and increases patient airway comfort. In addition in coolerclimates, warm air applied generally to the face area in and about thepatient interface is more comfortable than cold air. A range ofartificial humidification devices and systems are known, however theymay not fulfil the specialised requirements of a medical humidifier.

Medical humidifiers are used to increase humidity and/or temperature ofthe flow of air in relation to ambient air when required, typicallywhere the patient may be asleep or resting (e.g. at a hospital). Amedical humidifier for bedside placement may be small. A medicalhumidifier may be configured to only humidify and/or heat the flow ofair delivered to the patient without humidifying and/or heating thepatient's surroundings. Room-based systems (e.g. a sauna, an airconditioner, or an evaporative cooler), for example, may also humidifyair that is breathed in by the patient, however those systems would alsohumidify and/or heat the entire room, which may cause discomfort to theoccupants. Furthermore medical humidifiers may have more stringentsafety constraints than industrial humidifiers

While a number of medical humidifiers are known, they can suffer fromone or more shortcomings. Some medical humidifiers may provideinadequate humidification, some are difficult or inconvenient to use bypatients.

2.2.3.4 Data Management

There may be clinical reasons to obtain data to determine whether thepatient prescribed with respiratory therapy has been “compliant”, e.g.that the patient has used their RPT device according to certain a“compliance rule”. One example of a compliance rule for CPAP therapy isthat a patient, in order to be deemed compliant, is required to use theRPT device for at least four hours a night for at least 21 of 30consecutive days. In order to determine a patient's compliance, aprovider of the RPT device, such as a health care provider, may manuallyobtain data describing the patient's therapy using the RPT device,calculate the usage over a predetermined time period, and compare withthe compliance rule. Once the health care provider has determined thatthe patient has used their RPT device according to the compliance rule,the health care provider may notify a third party that the patient iscompliant.

There may be other aspects of a patient's therapy that would benefitfrom communication of therapy data to a third party or external system.

Existing processes to communicate and manage such data can be one ormore of costly, time-consuming, and error-prone.

2.2.3.5 Mandibular Repositioning

A mandibular repositioning device (MRD) or mandibular advancement device(MAD) is one of the treatment options for sleep apnea and snoring. It isan adjustable oral appliance available from a dentist or other supplierthat holds the lower jaw (mandible) in a forward position during sleep.The MRD is a removable device that a patient inserts into their mouthprior to going to sleep and removes following sleep. Thus, the MRD isnot designed to be worn all of the time. The MRD may be custom made orproduced in a standard form and includes a bite impression portiondesigned to allow fitting to a patient's teeth. This mechanicalprotrusion of the lower jaw expands the space behind the tongue, putstension on the pharyngeal walls to reduce collapse of the airway anddiminishes palate vibration.

In certain examples a mandibular advancement device may comprise anupper splint that is intended to engage with or fit over teeth on theupper jaw or maxilla and a lower splint that is intended to engage withor fit over teeth on the upper jaw or mandible. The upper and lowersplints are connected together laterally via a pair of connecting rods.The pair of connecting rods are fixed symmetrically on the upper splintand on the lower splint.

In such a design the length of the connecting rods is selected such thatwhen the MRD is placed in a patient's mouth the mandible is held in anadvanced position. The length of the connecting rods may be adjusted tochange the level of protrusion of the mandible. A dentist may determinea level of protrusion for the mandible that will determine the length ofthe connecting rods.

Some MRDs are structured to push the mandible forward relative to themaxilla while other MADs, such as the ResMed Narval CC™ MRD are designedto retain the mandible in a forward position. This device also reducesor minimises dental and temporo-mandibular joint (TMJ) side effects.Thus, it is configured to minimises or prevent any movement of one ormore of the teeth.

2.2.4 Diagnosis and Monitoring Systems

Clinical experts may be able to diagnose or monitor patients adequatelybased on person observation. However, there are circumstances where aclinical expert may not be available, or a clinical expert may not beaffordable. In some circumstances different clinical experts maydisagree on a patient's condition. A given clinical expert may apply adifferent standard at different times. With a busy clinical practice, aclinician may have difficulty keeping up with evolving patientmanagement guidelines.

Polysomnography (PSG) is a conventional system for diagnosis andprognosis of cardio-pulmonary disorders, and typically involves expertclinical staff to both apply and/or interpret. PSG typically involvesthe placement of 15 to 20 contact sensors on a person in order to recordvarious bodily signals such as electroencephalography (EEG),electrocardiography (ECG), electrooculograpy (EOG), electromyography(EMG), etc. However, while they may be suitable for their usualapplication in a clinical setting, such systems are complicated andpotentially expensive, and/or may be uncomfortable or impractical for apatient at home trying to sleep.

3 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the diagnosis, amelioration, treatment, or prevention ofrespiratory disorders having one or more of improved comfort, cost,efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe diagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to methods used in thediagnosis, amelioration, treatment or prevention of a respiratorydisorder.

An aspect of certain forms of the present technology is to providemethods and/or apparatus that improve the compliance of patients withrespiratory therapy.

A first form of the present technology includes a connector set with acompliant face seal between a first end and a second end of theconnector set and with a retention mechanism that couples the first endand the second end together.

A second form of the present technology comprises a fluid connector fordelivery of breathing gas to a patient from a respiratory pressuretherapy device, the fluid connector comprising a first end with a firstopening for a fluid flow, a seal portion extending around a periphery ofthe first opening, and a latching portion, a second end with a secondopening for the fluid flow, a sealing surface extending around aperiphery of the second opening and configured to engage the sealportion to form a face seal, and a complementary latching portionconfigured to engage with the latching portion, wherein the face sealallows the breathing gas to travel between the first opening and thesecond opening, and the engagement between the latching portion and thecomplementary latching portion secures the first end with the secondend.

A third form of the present technology comprises a system for providingrespiratory therapy to a patient, the system comprising a respiratorypressure therapy device; an air circuit; a patient interface connectedto the air circuit and a means for preventing the respiratory pressuretherapy device from being connected to the air circuit with an industrystandard connection.

A fourth form of the present technology comprises a method of providinga fluid connection to deliver breathing gas to a patient from arespiratory pressure therapy device, the method comprising engaging alatch between a first end and a second end of the fluid connection; andengaging a face seal around a first opening in the first end and arounda second opening in the second end, wherein one of the first end and thesecond end corresponds to the respiratory pressure therapy device.

A fifth form of the present technology comprises a first half of a fluidconnector system for delivery of breathing gas to a patient from arespiratory pressure therapy device, the first half comprising connectorportion with a first opening for a fluid flow, a seal portion extendingaround a periphery of the first opening, and a latching portion, whereinthe seal portion is configured to seal against a sealing surfaceextending around a periphery of a second opening to form a face sealwith a second half of the fluid connector system, and the latchingportion is configured to latch with another latching portion of thesecond half of the fluid connector system.

A sixth form of the present technology comprises a first half of a fluidconnector system for delivery of breathing gas to a patient from arespiratory pressure therapy device, the first half comprising aconnector portion with a first opening for a fluid flow, a sealingsurface around a periphery of the first opening, and a latching portion,wherein the sealing surface is configured to receive a seal portionextending around a periphery of a second opening to form a face sealwith a second half of the fluid connector system, and the latchingportion is configured to latch with another latching portion of thesecond half of the fluid connector system.

A seventh form of the present technology comprises a fluid connector fordelivery of breathing gas to a patient from a respiratory pressuretherapy device, the fluid connector comprising a first end with a firstinterior portion for a fluid flow and a first retaining portion, and asecond end with a second interior portion for the fluid flow and acomplementary retaining portion configured to engage with the retainingportion, wherein the first interior portion and the second interiorportion have a first shape perpendicular to a flow direction, theretaining portion and the complementary retaining portion have a secondshape perpendicular to the flow direction, and the first shape and thesecond shape are different.

An eighth form of the present technology comprises a system forproviding respiratory therapy to a patient, the system comprising arespiratory pressure therapy device; an air circuit; a patient interfaceconnected to the air circuit, the patient interface being speciallyadapted to operate with the respiratory pressure therapy device; and ameans for ensuring that the patient interface that is specially adaptedto operate with the respiratory pressure therapy device is connected tothe respiratory pressure therapy device.

In examples of at least one of the first through eighth forms of thepresent technology, (a) the first end is connected to a respiratorypressure therapy device including a blower and the second end isconnected to a fluid conduit; (b) the respiratory pressure therapydevice is configured to provide treatment pressure for the sleep relatedbreathing disorder; (c) the sealing surface is flat; (d) the sealingsurface is substantially perpendicular to a direction of the fluid flowfrom the first end to the second end; (e) the sealing surface isbeveled; (d) the sealing surface extends circumferentially around thesecond opening; (e) the sealing surface is formed on a flange thatextends radially from a tube defining the second opening; (f) the flangeextends substantially perpendicularly from the tube; (g) the tubeextends beyond the flange in a direction towards the seal portion; (h)the tube extends at least partially though the seal portion when thecomplementary latching portion is engaged with the latching portion; (i)the seal portion is compliant in a direction of engagement between thefirst end and the second end; (j) the seal portion includes afrustoconical portion; (k) the frustoconical portion contacts thesealing surface to form the face seal; (l) the seal portion includes apartial spherical surface; (m) the partial spherical surface contactsthe sealing surface to form the face seal; (n) the seal portion includesa bellows-shaped or partial bellows-shaped portion; (o) thebellows-shaped or partial bellows-shaped portion contacts the sealingsurface to form the face seal; (p) when the first end and the second endare connected the seal portion is configured to engage the sealingsurface before the latching portion and the complementary latchingportion engage; (q) the seal portion is compliant in a direction radialto an axis defined by a direction of engagement between the first endand the second end; (r) the seal portion is configured to expand andengage the sealing surface due to internal pressurization of the firstend when a gap exists between the seal portion and the sealing surfacein an unpressurized state; (s) contact between the seal portion and thesealing surface causes the seal portion to compress against the sealingand against an airflow direction that is from the first opening to thesecond opening; (t) compression of the seal portion does not causesignificant compressive forces; (u) a force required to compress theseal portion is less than a force required to engage the latchingportion with the complementary latching portion; (v) the force requiredto compress the seal portion is less than half of the force required toengage the latching portion with the complementary latching portion; (w)the force required to compress the seal portion is less than one tenthof the force required to engage the latching portion with thecomplementary latching portion; (x) at least one of the seal portion andthe sealing surface includes sufficient contact area between the sealportion and the sealing surface to form a seal when respective centersof the seal portion and the sealing surface are not aligned with oneanother; (y) the second end comprises an inner portion and an outerportion and the inner portion is rotatably coupled to the outer portion;(z) the inner portion comprises the sealing surface; (aa) the innerportion is rigidly connected to a fluid conduit; (bb) the outer portioncomprises the complementary latching portion; (cc) the complementarylatching portion comprises a cantilevered portion with a protrusion thatis configured to engage the latching portion; (dd) the cantileveredportion is configured to be depressed to engage or disengage thecomplementary latching portion from the latching portion and allowengagement or disengagement between the first end and the second end;(ee) the first end comprises a travel limit to constrain the second endfrom moving in a direction of engagement between the first end and thesecond end; (ff) the travel limit is a flange around the first openingand the second end comprises a stop surface configured to contact theflange; (gg) the latching portion constrains the second end from movingin a direction opposite to the direction of engagement, and the travellimit and latching portion together define a movement distance of thesecond end when the first end and the second end are engaged; (hh) theseal portion is configured to seal against the sealing surfacethroughout the movement distance, the movement distance being a non-zerodistance; (ii) the seal portion is configured to form a seal with thesealing surface with a worst case manufacturing tolerance and after apredetermined amount of wear and/or creep in the fluid connector; (jj)the fluid connector is configured to provide negligible pressure dropwhen air is flowing through the fluid connector throughout a patient'sbreathing cycle and at pressures between 4 cm H₂O to 40 cm H₂O; (kk) thefirst end is a female connection and the second end is a maleconnection; (ll) the female connection and the male connection haveprofiles that are non-circular; (mm) the first end includes a port influid communication with an interior of the seal portion and separatedfrom the first opening and the second opening; (nn) the first openingand the second opening are interior portions of tubes; (oo) the firstend is connected to a respiratory pressure therapy device including ablower and the second end is connected to an adapter for a fluid conduitconnector; (pp) the fluid connector further comprises an industrystandard fluid connection, wherein the industry standard fluidconnection is in fluid communication with the first opening and on anend opposite the seal portion; (qq) the fluid connector furthercomprises an industry standard fluid connection, wherein the industrystandard fluid connection is in fluid communication with the firstopening and on an end opposite the sealing surface; (rr) the first shapeis a circle and the second shape includes properties of a circle and asquare; and/or (ss) one of the first interior portion and the secondinterior portion includes a first male portion and the other of thefirst interior portion and the second interior portion includes a firstfemale portion, the first male portion and the first female portionincluding the first shape, and one of the retaining portion and thecomplementary retaining portion includes a second male portion and theother of the retaining portion and the complementary retaining portionincludes a second female portion, the second male portion and the secondfemale portion including the second shape.

An aspect of one form of the present technology is a portable RPTdevice, including a fluid connector, that may be carried by a person,e.g., around the home of the person.

Another aspect of the present technology is directed to a vent assemblyfor a respiratory pressure therapy (RPT) system. The vent assemblycomprising: a vent housing defining a central orifice for the flow ofpressurized gas to pass through the vent assembly from the deliveryconduit to the patient interface, the vent housing having an annularsurface around the central orifice, and the annular surface having aplurality of holes to discharge pressurized gas to atmosphere; and amembrane positioned adjacent to the annular surface, wherein themembrane is movable such that the membrane is urged against the annularsurface of the vent housing as the pressure of the pressurized gaswithin the vent assembly increases.

Another aspect of the present technology is directed to an RPT system,comprising: the vent assembly described in the preceding paragraph; anRPT device configured to generate a flow of pressurized gas in the rangeof 4-20 cm H2O; a patient interface configured to deliver the flow ofpressurized gas to the patient's airways, the patient interface beingnon-vented; and a delivery conduit configured to deliver the flow ofpressurized gas from the RPT device to the patient interface.

In examples of the vent assembly and the RPT system described in the twopreceding paragraphs, (a) the plurality of holes may comprise a firstgroup of holes and a second group of holes, the first group of holesbeing proximal to the central orifice relative to the second group ofholes, (b) the membrane may be shaped and dimensioned such that themembrane does not cover the first group of holes, (c) the membrane maybe structured to cover more of the second group of holes as the pressureof the pressurized gas within the vent assembly increases, (d) the firstgroup of holes may be positioned upstream of the second group of holesrelative to the flow of pressurized gas, (e) the vent assembly mayfurther comprise a retaining structure to retain the membrane in aposition adjacent to the annular surface of the vent housing, (f) themembrane may further comprise an elastic material, (g) the membrane maybe ring-shaped, (h) the membrane may not be joined to the vent housing,(i) the membrane may be shaped and dimensioned such that an outer edgeof the membrane is adjacent to an inner periphery of the vent housing,and/or (j) each of the plurality of holes may have a shape thatconverges from an internal surface of the vent housing to an externalsurface of the vent housing.

Another aspect of the present technology is directed to a vent adaptorfor a for a respiratory pressure therapy (RPT) system. The vent adaptorcomprises: a vent assembly comprising: a vent housing defining a centralorifice for the flow of pressurized gas to pass through the ventassembly from the delivery conduit to the patient interface, the venthousing having an annular surface around the central orifice, and theannular surface having a plurality of holes to discharge pressurized gasto atmosphere; and a membrane positioned adjacent to the annularsurface; and a diffusing member.

Another aspect of the present technology is directed to an RPT system.The RPT system comprising: the vent adaptor described in the precedingparagraph; an RPT device configured to generate a flow of pressurizedgas in the range of 4-20 cm H2O; a patient interface configured todeliver the flow of pressurized gas to the patient's airways, thepatient interface being non-vented; and a delivery conduit configured todeliver the flow of pressurized gas from the RPT device to the patientinterface.

In examples of the vent adaptor and the RPT system described in the twopreceding paragraphs, (a) the membrane may be movable such that themembrane is urged against the annular surface of the vent housing as thepressure of the pressurized gas within the vent assembly increases, (b)the plurality of holes may comprise a first group of holes and a secondgroup of holes, the first group of holes being proximal to the centralorifice relative to the second group of holes, (c) the membrane may beshaped and dimensioned such that the membrane does not cover the firstgroup of holes, (d) the membrane may be structured to cover more of thesecond group of holes as the pressure of the pressurized gas within thevent assembly increases, (e) the first group of holes may be positionedupstream of the second group of holes relative to the flow ofpressurized gas, (f) the vent adaptor may further comprise a retainingstructure to retain the membrane in a position adjacent to the annularsurface of the vent housing, (g) the membrane may further comprise anelastic material, (h) the membrane may be ring-shaped, (i) the membranemay not be joined to the vent housing, (j) the membrane may be shapedand dimensioned such that an outer edge of the membrane is adjacent toan inner periphery of the vent housing, (k) each of the plurality ofholes may have a shape that converges from an internal surface of thevent housing to an external surface of the vent housing, (l) the ventadaptor may comprise a heat and moisture exchanger (HME) that may bepositioned downstream of the plurality of holes relative to the flow ofpressurized gas, (m) the diffusing member may be positioned on theexterior of the vent housing to at least partly cover the plurality ofholes, (n) the vent adaptor may further comprise a blocking memberhaving an air-impermeable material, the blocking member preventing gasexiting from the plurality of holes from flowing through the diffusingmember to atmosphere in a linear path, (o) the diffusing member and theblocking member may be configured to direct the gas exiting from theplurality of holes outward from the diffusing member in an orientationdifferent than the plurality of holes, (p) the diffusing member mayprovide a flow path parallel to a surface of the blocking member that isin contact with the diffusing member, (q) the diffusing member may be aporous material, (r) the diffusing member may be an open cell foam,and/or (s) the diffusing member may be a fibrous material.

An aspect of the present technology is directed to a vent system for usewith a patient interface during respiratory therapy of a patient with atherapy flow of gas pressurized above ambient pressure, the vent systemproviding a vent flow of gas to discharge gas exhaled by the patientfrom a pressurized volume, the vent flow being continuous during therespiratory therapy. The vent system comprises a vent housing comprisinga base having an inlet for the therapy flow of gas extending through thebase and at least one first orifice extending through the base to allowgas to be discharged to atmosphere from the pressurized volume; at leastone second orifice to allow gas to be discharged to atmosphere from thepressurized volume; and a membrane positioned adjacent to the base.

An aspect of the present technology is directed to a vent system for usewith a patient interface during respiratory therapy of a patient with atherapy flow of gas pressurized above ambient pressure, the vent systemproviding a vent flow of gas to discharge gas exhaled by the patientfrom a pressurized volume, the vent flow being continuous during therespiratory therapy. The vent system comprises a vent housing comprisinga base having at least one first orifice extending through the base toallow gas to be discharged to atmosphere from the pressurized volume; atleast one second orifice to allow gas to be discharged to atmospherefrom the pressurized volume; and a membrane positioned adjacent to thebase, wherein the pressurized volume is in fluid communication withatmosphere through the at least one first orifice and the at least onesecond orifice throughout a therapeutic pressure range, and wherein themembrane is elastically deformable due to pressure within thepressurized volume to apportion the vent flow between the at least onefirst orifice and the at least one second orifice throughout thetherapeutic pressure.

In examples, (a) the vent housing may comprise an outer wall and aninner wall, the inner wall defining an inlet for the therapy flow ofgas, and the base may be positioned between the outer wall and the innerwall, (b) the base the base may comprise an inner base and an outerbase, (c) the outer base may be adjacent to the outer wall, the innerbase may be adjacent to the outer base, and the inner base may beadjacent to the inner wall, (d) the at least one first orifice maycomprise a plurality of inner orifices and the at least one secondorifice may comprise a plurality of outer orifices, (e) the plurality ofouter orifices may pass through the outer base and the plurality ofinner orifices may pass between the outer base and the inner base, (f)the vent system may comprise a plurality of base connectors to join theinner base and the outer base and to divide the plurality of innerorifices, (g) the vent system may comprise a plurality of membranespacers extending from the inner base, (h) the membrane may be supportedover the plurality of inner orifices on the outer base and the membranespacers, (i) the vent housing may comprise a base divider between theinner base and the outer base and the membrane may be supported over theplurality of inner orifices on the base divider and the membranespacers, (j) the plurality of membrane spacers may define a plurality ofmembrane spacer gaps between adjacent ones of the plurality of membranespacers, (k) the membrane may include an atmosphere-side surfaceadjacent to the inner base and the outer base of the vent housing and aninner surface defining a membrane opening and an inner base membranepassage for the washout flow may be defined between the atmosphere-sidesurface of the membrane and the inner base of the vent housing, (l) aninner wall membrane passage for the washout flow may be defined betweenthe inner surface of the membrane and the inner wall of the venthousing, (m) the inner base may comprise a plurality of inner base slotsbetween adjacent ones of the plurality of membrane spacers, (n) theouter base may comprise a plurality of lateral membrane supports thatare configured to prevent the membrane from covering the plurality ofouter orifices, (o) the vent housing may comprise a plurality ofrecesses opposite the outer base and at least one of the plurality ofouter orifices may open into a corresponding one of the plurality ofrecesses, (p) the inner wall may extend above the inner base and theouter base, (q) the inner wall may extend below the inner base and theouter base, (r) the membrane may comprises an elastically deformablematerial, (s) the elastically deformable material may comprise silicone,(t) the vent housing may be formed from a single, homogeneous piece of arelatively rigid material, (u) the relatively rigid material may bepolycarbonate, (v) the outer wall, the inner wall, the inner base, theouter base, and the membrane may be circular, (w) the outer wall, theinner wall, the inner base, the outer base, and the membrane may beconcentric, and/or (x) the membrane may not be attached to the venthousing such that the membrane is freely movable towards and away fromthe base.

Another aspect of the present technology is directed to a patientinterface comprising: a seal-forming structure; a plenum chamber joinedto the seal-forming structure; a positioning and stabilising structureto secure the patient interface on the patient in use; and the ventsystem according to any of the aspects and/or examples disclosed in thetwo immediately preceding paragraphs. The patient interface may comprisea vent connector tube or a decoupling structure to fluidly connect thevent system to the plenum chamber.

Another aspect of the present technology is directed to a vent systemfor use with a patient interface during respiratory therapy of a patientwith a therapy flow of gas pressurized above ambient pressure, the ventsystem providing a vent flow of gas to discharge gas exhaled by thepatient from a pressurized volume, the vent flow being continuous duringthe respiratory therapy. The vent system comprises a vent housing a basehaving at least one first orifice extending through the base to allowgas to be discharged to atmosphere from the pressurized volume; at leastone second orifice to allow gas to be discharged to atmosphere from thepressurized volume; and a membrane positioned adjacent to the base,wherein the pressurized volume is in fluid communication with atmospherethrough the at least one first orifice and the at least one secondorifice throughout a therapeutic pressure range, wherein the membrane isconfigured such that an increase in pressure within the pressurizedvolume causes the membrane to restrict a first vent flow through the atleast one first orifice throughout the therapeutic pressure range, andwherein restriction of the first vent flow through the at least onefirst orifice causes an increase in a second vent flow through the atleast one second orifice such that the vent flow through the at leastone first orifice and the at least one second orifice is approximatelyconstant throughout the therapeutic pressure range.

In examples, (a) the vent housing may comprise an outer wall and aninner wall, the inner wall defining an inlet for the therapy flow ofgas, and the base may be positioned between the outer wall and the innerwall, (b) the washout flow may be greater than or equal to the sum ofthe first vent flow and the second vent flow, (c) the membrane may beelastically deformable toward the base in use such that the first ventflow is restricted as the membrane is deflected towards the base, (d)the membrane may be configured to deflect closer to the base as thetherapy pressure increases above a threshold therapy pressure value, (e)the membrane may be configured to decrease the first vent flow such thatthe second vent flow increases as the membrane is deflected closer tothe base due to increasing the therapy pressure above the thresholdtherapy pressure value, (f) the at least one first orifice may comprisea plurality of inner orifices and the at least one second orifice maycomprise a plurality of outer orifices, (g) the base may comprise aninner base and an outer base, (h) the vent system may comprise aplurality of membrane spacers extending from the inner base, (i) themembrane may be supported over the plurality of inner orifices on theouter base and the membrane spacers such that increasing the therapypressure above a threshold therapy pressure value causes the membrane todeflect towards the inner base, (j) the membrane may be configured suchthat a membrane-inner base gap defined between the membrane and theinner base decreases as the therapy pressure is increased above thethreshold therapy pressure value, (k) the membrane may be configuredsuch that as the membrane-inner base gap decreases the first vent flowdecreases and the second vent flow increases, (l) the membrane maycomprise an elastically deformable material, (m) the elasticallydeformable material may comprise silicone, (n) the vent housing may beformed from a single, homogeneous piece of a relatively rigid material,(o) the relatively rigid material may be polycarbonate, (p) the outerwall, the inner wall, the inner base, the outer base, and the membranemay be circular, (q) the outer wall, the inner wall, the inner base, theouter base, and the membrane may be concentric, and/or (r) the membranemay not be attached to the vent housing such that the membrane is freelymovable towards and away from the base.

Another aspect of the present technology is directed to a patientinterface comprising: a seal-forming structure; a plenum chamber joinedto the seal-forming structure; a positioning and stabilising structureto secure the patient interface on the patient in use; and the ventsystem according to any of the aspects and/or examples disclosed in thetwo immediately preceding paragraphs. The patient interface may comprisea vent connector tube or a decoupling structure to fluidly connect thevent system to the plenum chamber.

Another aspect of the present technology is directed to a patientinterface that may comprise: a plenum chamber pressurisable to atherapeutic pressure of at least 6 cmH2O above ambient air pressure,said plenum chamber including a plenum chamber inlet port sized andstructured to receive a flow of air at the therapeutic pressure forbreathing by a patient; a seal-forming structure constructed andarranged to form a seal with a region of the patient's face surroundingan entrance to the patient's airways such that the flow of air at saidtherapeutic pressure is delivered to at least an entrance to thepatient's nares, the seal-forming structure constructed and arranged tomaintain said therapeutic pressure in the plenum chamber throughout thepatient's respiratory cycle in use; a positioning and stabilisingstructure to provide an elastic force to hold the seal-forming structurein a therapeutically effective position on the patient's head, thepositioning and stabilising structure comprising a tie, the tie beingconstructed and arranged so that at least a portion overlies a region ofthe patient's head superior to an otobasion superior of the patient'shead in use, and a portion of the tie being dimensioned and structuredto engage in use a portion of the patient's head in a region of aparietal bone, wherein the positioning and stabilising structure has anon-rigid decoupling portion; and a vent system for use with a patientinterface during respiratory therapy of a patient with a therapy flow ofgas pressurized above ambient pressure, the vent system providing a ventflow of gas to discharge gas exhaled by the patient from a pressurizedvolume, the vent flow being continuous during the respiratory therapy,the vent system comprising: a vent housing a base having at least onefirst orifice extending through the base to allow gas to be dischargedto atmosphere from the pressurized volume; at least one second orificeto allow gas to be discharged to atmosphere from the pressurized volume;and a membrane positioned adjacent to the base, wherein the pressurizedvolume is in fluid communication with atmosphere through the at leastone first orifice and the at least one second orifice throughout atherapeutic pressure range, wherein the membrane is configured such thatan increase in pressure within the pressurized volume causes themembrane to restrict a first vent flow through the at least one firstorifice throughout the therapeutic pressure range, and whereinrestriction of the first vent flow through the at least one firstorifice causes an increase in a second vent flow through the at leastone second orifice such that the vent flow through the at least onefirst orifice and the at least one second orifice is approximatelyconstant throughout the therapeutic pressure range, and wherein thepatient interface is configured to allow the patient to breath fromambient through their mouth in the absence of a flow of pressurised airthrough the plenum chamber inlet port, or the patient interface isconfigured to leave the patient's mouth uncovered.

In examples, (a) the vent housing may comprise an outer wall and aninner wall, the inner wall defining an inlet for the therapy flow ofgas, and the base may be positioned between the outer wall and the innerwall, (b) the washout flow may be greater than or equal to the sum ofthe first vent flow and the second vent flow, (c) the membrane may beelastically deformable toward the base in use such that the first ventflow is restricted as the membrane is deflected towards the base, (d)the membrane may be configured to deflect closer to the base as thetherapeutic pressure increases above a threshold therapeutic pressurevalue, (e) the membrane may be configured to decrease the first ventflow such that the second vent flow increases as the membrane isdeflected closer to the base due to increasing the therapeutic pressureabove the threshold therapeutic pressure value, (f) the base maycomprise an inner base and an outer base, (g) the at least one firstorifice may comprise a plurality of inner orifices and the at least onesecond orifice may comprise a plurality of outer orifices, (h) the ventsystem may comprise a plurality of membrane spacers extending from theinner base, (i) the membrane may be supported over the plurality ofinner orifices on the outer base and the membrane spacers, (j) the venthousing may comprise a base divider between the inner base and the outerbase and the membrane may be supported over the plurality of innerorifices on the base divider and the membrane spacers, (k) the outerbase may comprise a plurality of lateral membrane supports that areconfigured to prevent the membrane from covering the plurality of outerorifices, (l) the membrane may comprise an elastically deformablematerial, (m) the elastically deformable material may comprise silicone,(n) the vent housing may be formed from a single, homogeneous piece of arelatively rigid material, (o) the relatively rigid material may bepolycarbonate, (p) the outer wall, the inner wall, the inner base, theouter base, and the membrane may be circular, (q) the outer wall, theinner wall, the inner base, the outer base, and the membrane may beconcentric, (r) the membrane may not be attached to the vent housingsuch that the membrane is freely movable towards and away from the base,and/or (s) the patient interface may comprise a vent connector tube or adecoupling structure to fluidly connect the vent system to the plenumchamber.

Another aspect of the present technology is directed to a patientinterface that may comprise: a plenum chamber pressurisable to atherapeutic pressure of at least 6 cmH2O above ambient air pressure,said plenum chamber including a plenum chamber inlet port sized andstructured to receive a flow of air at the therapeutic pressure forbreathing by a patient; a seal-forming structure constructed andarranged to form a seal with a region of the patient's face surroundingan entrance to the patient's airways such that the flow of air at saidtherapeutic pressure is delivered to at least an entrance to thepatient's nares, the seal-forming structure constructed and arranged tomaintain said therapeutic pressure in the plenum chamber throughout thepatient's respiratory cycle in use; a positioning and stabilisingstructure to provide an elastic force to hold the seal-forming structurein a therapeutically effective position on the patient's head, thepositioning and stabilising structure comprising a tie, the tie beingconstructed and arranged so that at least a portion overlies a region ofthe patient's head superior to an otobasion superior of the patient'shead in use, and a portion of the tie being dimensioned and structuredto engage in use a portion of the patient's head in a region of aparietal bone, wherein the positioning and stabilising structure has anon-rigid decoupling portion; and a vent system to provide a vent flowof gas to discharge gas exhaled by the patient from a pressurizedvolume, the vent flow being continuous during the respiratory therapy,the vent flow comprising a first vent flow and a second vent flow, thevent system comprising: a vent housing comprising a base having at leastone first orifice extending through the base for the first vent flow; atleast one second orifice for the second vent flow; and a membranepositioned adjacent to the base, wherein the pressurized volume is influid communication with atmosphere through the at least one firstorifice and the at least one second orifice throughout a therapeuticpressure range, wherein the membrane is configured to be elasticallydeformed by pressure within the pressurized volume such that increaseddeformation due to increased pressure decreases the first vent flowthrough the at least one first orifice and increases the second ventflow through the at least one second orifice to maintain a substantiallyconstant vent flow throughout the therapeutic pressure range, andwherein the patient interface is configured to allow the patient tobreath from ambient through their mouth in the absence of a flow ofpressurised air through the plenum chamber inlet port, or the patientinterface is configured to leave the patient's mouth uncovered.

In examples, (a) the vent housing may comprise an outer wall and aninner wall, the inner wall defining an inlet for the therapy flow ofgas, and the base may be positioned between the outer wall and the innerwall, (b) the washout flow may be greater than or equal to the sum ofthe first vent flow and the second vent flow, (c) the membrane may beelastically deformable toward the base in use such that the first ventflow is restricted as the membrane is deflected towards the base, (d)the membrane may be configured to deflect closer to the base as thetherapeutic pressure increases above a threshold therapeutic pressurevalue, (e) the membrane may be configured to decrease the first ventflow such that the second vent flow increases as the membrane isdeflected closer to the base due to increasing the therapeutic pressureabove the threshold therapeutic pressure value, (f) the base maycomprise an inner base and an outer base, (g) the at least one firstorifice may comprise a plurality of inner orifices and the at least onesecond orifice may comprise a plurality of outer orifices, (h) the ventsystem may comprise a plurality of membrane spacers extending from theinner base, (i) the membrane may be supported over the plurality ofinner orifices on the outer base and the membrane spacers, (j) the venthousing may comprise a base divider between the inner base and the outerbase and the membrane may be supported over the plurality of innerorifices on the base divider and the membrane spacers, (k) the outerbase may comprise a plurality of lateral membrane supports that areconfigured to prevent the membrane from covering the plurality of outerorifices, (l) the membrane may comprise an elastically deformablematerial, (m) the elastically deformable material may comprise silicone,(n) the vent housing may be formed from a single, homogeneous piece of arelatively rigid material, (o) the relatively rigid material may bepolycarbonate, (p) the outer wall, the inner wall, the inner base, theouter base, and the membrane may be circular, (q) the outer wall, theinner wall, the inner base, the outer base, and the membrane may beconcentric, (r) the membrane may not be attached to the vent housingsuch that the membrane is freely movable towards and away from the base,and/or (s) the patient interface may comprise a vent connector tube or adecoupling structure to fluidly connect the vent system to the plenumchamber.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Also, various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

4 BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

4.1 Treatment Systems

FIG. 1A shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal pillows, receiving a supply ofair at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an aircircuit 4170 to the patient 1000. A bed partner 1100 is also shown.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receiving a supply of airat positive pressure from an RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receiving a supply ofair at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an aircircuit 4170 to the patient 1000.

4.2 Respiratory System and Facial Anatomy

FIG. 2A shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 2B shows a view of a human upper airway including the nasal cavity,nasal bone, lateral nasal cartilage, greater alar cartilage, nostril,lip superior, lip inferior, larynx, hard palate, soft palate,oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

FIG. 2C is a front view of a face with several features of surfaceanatomy identified including the lip superior, upper vermilion, lowervermilion, lip inferior, mouth width, endocanthion, a nasal ala,nasolabial sulcus and cheilion. Also indicated are the directionssuperior, inferior, radially inward and radially outward.

FIG. 2D is a side view of a head with several features of surfaceanatomy identified including glabella, sellion, pronasale, subnasale,lip superior, lip inferior, supramenton, nasal ridge, alar crest point,otobasion superior and otobasion inferior. Also indicated are thedirections superior & inferior, and anterior & posterior.

FIG. 2E is a further side view of a head. The approximate locations ofthe Frankfort horizontal and nasolabial angle are indicated. The coronalplane is also indicated.

FIG. 2F shows a base view of a nose with several features identifiedincluding naso-labial sulcus, lip inferior, upper Vermilion, naris,subnasale, columella, pronasale, the major axis of a naris and thesagittal plane.

FIG. 2G shows a side view of the superficial features of a nose.

FIG. 2H shows subcutaneal structures of the nose, including lateralcartilage, septum cartilage, greater alar cartilage, lesser alarcartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue,frontal process of the maxilla and fibrofatty tissue.

FIG. 2I shows a medial dissection of a nose, approximately severalmillimeters from a sagittal plane, amongst other things showing theseptum cartilage and medial crus of greater alar cartilage.

FIG. 2J shows a front view of the bones of a skull including thefrontal, nasal and zygomatic bones. Nasal concha are indicated, as arethe maxilla, and mandible.

FIG. 2K shows a lateral view of a skull with the outline of the surfaceof a head, as well as several muscles. The following bones are shown:frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal,temporal and occipital. The mental protuberance is indicated. Thefollowing muscles are shown: digastricus, masseter, sternocleidomastoidand trapezius.

FIG. 2L shows an anterolateral view of a nose.

4.3 Patient Interface

FIG. 3A shows a patient interface in the form of a nasal mask inaccordance with one form of the present technology.

FIG. 3B shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a positive sign, and a relatively large magnitude whencompared to the magnitude of the curvature shown in FIG. 3C.

FIG. 3C shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a positive sign, and a relatively small magnitude whencompared to the magnitude of the curvature shown in FIG. 3B.

FIG. 3D shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a value of zero.

FIG. 3E shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a negative sign, and a relatively small magnitude whencompared to the magnitude of the curvature shown in FIG. 3F.

FIG. 3F shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a negative sign, and a relatively large magnitude whencompared to the magnitude of the curvature shown in FIG. 3E.

FIG. 3G shows a cushion for a mask that includes two pillows. Anexterior surface of the cushion is indicated. An edge of the surface isindicated. Dome and saddle regions are indicated.

FIG. 3H shows a cushion for a mask. An exterior surface of the cushionis indicated. An edge of the surface is indicated. A path on the surfacebetween points A and B is indicated. A straight line distance between Aand B is indicated. Two saddle regions and a dome region are indicated.

4.4 RPT Device

FIG. 4A shows an RPT device in accordance with one form of the presenttechnology.

FIG. 4B is a schematic diagram of the pneumatic path of an RPT device inaccordance with one form of the present technology. The directions ofupstream and downstream are indicated.

FIG. 4C is a schematic diagram of the electrical components of an RPTdevice in accordance with one form of the present technology.

FIG. 4D is a schematic diagram of the algorithms implemented in an RPTdevice in accordance with one form of the present technology.

FIG. 4E is a flow chart illustrating a method carried out by the therapyengine module of FIG. 4D in accordance with one form of the presenttechnology.

4.5 Humidifier

FIG. 5A shows an isometric view of a humidifier in accordance with oneform of the present technology.

FIG. 5B shows an isometric view of a humidifier in accordance with oneform of the present technology, showing a humidifier reservoir 5110removed from the humidifier reservoir dock 5130.

FIG. 5C shows a schematic of a humidifier in accordance with one form ofthe present technology.

4.6 Vent Adaptor

FIG. 6A shows a side view of a fluid connector with a first end and asecond end mated with one another.

FIG. 6B shows a side, cross-sectional view of a fluid connector with afirst end and a second end disengaged from one another.

FIG. 6C shows a side, cross-sectional view of a fluid connector with afirst end and a second end mated with one another.

FIG. 6D shows a perspective view of a fluid connector with a first endand a second end separated from one another with an interior of thefirst end being visible.

FIG. 6E shows a cross-sectional view of a fluid connector with anadditional fluid port.

FIG. 6F shows a fluid connector with a first end and a second endconnected together and the first end integrated into an RTP device.

FIG. 6G shows a fluid connector with a first end and a second enddisconnected and the first end integrated into an RTP device

FIG. 6H shows a perspective view of a fluid connector with a first endand a second end separated from one another with the sealing surface ofthe second end being visible.

FIG. 7A shows a perspective view of a vent adaptor according to anexample of the present technology.

FIG. 7B shows a side view of a vent adaptor according to an example ofthe present technology.

FIG. 7C shows a top view of a vent adaptor according to an example ofthe present technology.

FIG. 7D shows a cross-section view of a vent adaptor according to anexample of the present technology taken through line 7D-7D of FIG. 7C.

FIG. 7E shows an exploded view of a vent adaptor according to an exampleof the present technology.

FIG. 7F shows another exploded view of a vent adaptor according to anexample of the present technology.

FIG. 8A shows a perspective view of a vent housing according to anexample of the present technology.

FIG. 8B shows another perspective view of a vent housing according to anexample of the present technology.

FIG. 8C shows a side view of a vent housing according to an example ofthe present technology.

FIG. 8D shows another side view of a vent housing according to anexample of the present technology.

FIG. 8E shows a top view of a vent housing according to an example ofthe present technology.

FIG. 8F shows a cross-section view of a vent housing according to anexample of the present technology taken through line 8F-8F of FIG. 8E.

FIG. 9A shows a perspective view of a vent housing connector accordingto an example of the present technology.

FIG. 9B shows another perspective view of a vent housing connectoraccording to an example of the present technology.

FIG. 9C shows a side view of a vent housing connector according to anexample of the present technology.

FIG. 9D shows another side view of a vent housing connector according toan example of the present technology.

FIG. 9E shows a top view of a vent housing connector according to anexample of the present technology.

FIG. 10A shows a perspective view of a bellows seal according to anexample of the present technology.

FIG. 10B shows another perspective view of a bellows seal according toan example of the present technology.

FIG. 10C shows a side view of a bellows seal according to an example ofthe present technology.

FIG. 10D shows another side view of a bellows seal according to anexample of the present technology.

FIG. 10E shows a bottom view of a bellows seal according to an exampleof the present technology.

FIG. 11A shows a perspective view of a vent adaptor connector accordingto an example of the present technology.

FIG. 11B shows another perspective view of a vent adaptor connectoraccording to an example of the present technology.

FIG. 11C shows a side view of a vent adaptor connector according to anexample of the present technology.

FIG. 11D shows another side view of a vent adaptor connector accordingto an example of the present technology.

FIG. 11E shows a bottom view of a vent adaptor connector according to anexample of the present technology.

FIG. 12A shows a perspective view of a heat and moisture exchanger (HME)clip according to an example of the present technology.

FIG. 12B shows a side view of a heat and moisture exchanger (HME) clipaccording to an example of the present technology.

FIG. 12C shows another side view of a heat and moisture exchanger (HME)clip according to an example of the present technology.

FIG. 12D shows another side view of a heat and moisture exchanger (HME)clip according to an example of the present technology.

FIG. 13A shows a perspective view of a heat and moisture exchanger (HME)housing according to an example of the present technology.

FIG. 13B shows a side view of a heat and moisture exchanger (HME)housing according to an example of the present technology.

FIG. 13C shows another side view of a heat and moisture exchanger (HME)housing according to an example of the present technology.

FIG. 13D shows a top view of a heat and moisture exchanger (HME) housingaccording to an example of the present technology.

FIG. 14A shows a perspective view of a conduit connector according to anexample of the present technology.

FIG. 14B shows a top view of a conduit connector according to an exampleof the present technology.

FIG. 14C shows a side view of a conduit connector according to anexample of the present technology.

FIG. 14D shows a front view of a conduit connector according to anexample of the present technology.

FIG. 15A shows a perspective view of a vent adaptor according to anexample of the present technology.

FIG. 15B shows another perspective view of a vent adaptor according toan example of the present technology.

FIG. 15C shows an exploded view of a vent adaptor according to anexample of the present technology.

FIG. 15D shows an exploded view of a vent adaptor according to anexample of the present technology.

FIG. 15E shows a side view of a vent adaptor according to an example ofthe present technology.

FIG. 15F shows a cross-section view of a vent adaptor according to anexample of the present technology taken through line 15F-15F of FIG.15B.

FIG. 16 shows a graph of vent flow from a full face mask compared tovent flow from a constant flow vent (CFV) according to the presenttechnology over a range of therapeutic pressures.

FIG. 17 shows a diagram of a patient receiving therapy according to anexample of the present technology.

FIG. 18 shows a graph of vent flow from a full face mask compared tovent flow from a constant flow vent (CFV) according to the presenttechnology over a range of therapeutic pressures.

FIG. 19 shows a graph of vent flow from a constant flow vent (CFV) only,from a passive vent only, and a combination of both according to thepresent technology over a range of therapeutic pressures.

FIG. 20 shows an example of a constant flow vent (CFV) membraneaccording to an example of the present technology.

FIG. 21A shows a cross-section view of a vent adaptor according to anexample of the present technology.

FIG. 21B shows an exploded view of a constant flow vent (CFV) of a ventadaptor according to an example of the present technology.

FIG. 21C shows a rear view of a constant flow vent (CFV) of a ventadaptor according to an example of the present technology.

FIG. 21D shows a perspective view of a constant flow vent (CFV) of avent adaptor according to an example of the present technology.

FIG. 21E shows another perspective view of a constant flow vent (CFV) ofa vent adaptor according to an example of the present technology.

FIG. 21F shows a cross-section view of a constant flow vent (CFV) of avent adaptor according to an example of the present technology.

FIG. 22 shows an exploded view of a vent adaptor according to an exampleof the present technology.

FIG. 23 shows a chart of exemplary patient interfaces according to thepresent technology.

FIG. 24A shows a cross-section view of a vent adaptor according to anexample of the present technology.

FIG. 24B shows a perspective view of a vent adaptor according to anexample of the present technology.

FIG. 25A shows a cross sectional view of a HME 7000 comprising a singlelayer 7001 in accordance with one aspect of the present technology.

FIG. 25B shows examples of a single corrugation 7030 of a HME 7000 inaccordance with one aspect of the present technology.

FIG. 25C is a schematic diagram showing a HME 7000 comprising aplurality of layers 7001 stacked along both a vertical and horizontalaxis.

FIG. 25D is a diagram that illustrates a HME under preload to compressthe corrugations in a fixed volume such that the number of layers 7001is increased within the fixed volume.

FIG. 25E displays a corrugated structure 7002 comprising a plurality ofcorrugations 7030, wherein the corrugated structure is rolled to form aHME 7000.

FIG. 26 depicts orifices, a diffusing member and a blocking member thatform part of a gas washout vent.

FIG. 27 depicts orifices, a diffusing member and a blocking member thatform part of a gas washout vent where holes are provided in the blockingmember.

FIG. 28 depicts an exploded view of orifices, a diffusing member and ablocking member that form part of a gas washout vent formed circularlyabout a central hole.

FIG. 29 depicts a simplified view of orifices, a diffusing member and ablocking member that form part of a gas washout vent formed circularlyabout a central hole.

FIG. 30 depicts a cross-sectional view taken through line 30-30 of FIG.29 .

FIG. 31A depicts a partial view of an elbow with a gas washout vent withone annular outlet.

FIG. 31B depicts an axial view of orifices in the gas washout vent ofFIG. 31B.

FIG. 31C depicts a cross-sectional view taken through the plane of thedrawing of FIG. 31 , which is equivalent to the plane labelled 31C-31Cin FIG. 31B.

FIG. 32A depicts an elbow with a ball and socket joint and gas washoutvent.

FIG. 32B depicts an exploded view of the elbow of FIG. 32A.

FIG. 32C depicts a side view of the elbow.

FIG. 32D depicts a cross-sectional view taking through line 32D-32D ofFIG. 32C.

FIG. 33A depicts a perspective view of a vent adaptor according to anexample of the present technology.

FIG. 33B depicts another perspective view of a vent adaptor according toan example of the present technology.

FIG. 33C depicts a superior view of a vent adaptor according to anexample of the present technology.

FIG. 33D depicts an inferior view of a vent adaptor according to anexample of the present technology.

FIG. 33E depicts a lateral view of a vent adaptor according to anexample of the present technology.

FIG. 33F depicts a cross-sectional view of a vent adaptor taken throughline 33F-33F of FIG. 33C according to an example of the presenttechnology.

FIG. 33G depicts an exploded view of a vent adaptor according to anexample of the present technology.

FIG. 34A depicts a perspective view of a vent assembly for a ventadaptor according to an example of the present technology.

FIG. 34B depicts another perspective view of a vent assembly for a ventadaptor according to an example of the present technology.

FIG. 34C depicts a posterior view of a vent assembly for a vent adaptoraccording to an example of the present technology.

FIG. 34D depicts an anterior view of a vent assembly for a vent adaptoraccording to an example of the present technology.

FIG. 34E depicts a lateral view of a vent assembly for a vent adaptoraccording to an example of the present technology.

FIG. 34F depicts a cross-sectional view of a vent assembly for a ventadaptor taken through line 34F-34F of FIG. 34C according to an exampleof the present technology.

FIG. 34G depicts an exploded view of a vent assembly for a vent adaptoraccording to an example of the present technology.

FIG. 35 depicts a perspective view of a vent adaptor with a patientinterface according to an example of the present technology.

FIG. 36A depicts a perspective view of an air circuit according to anexample of the present technology.

FIG. 36B depicts another perspective view of an air circuit according toan example of the present technology.

FIG. 36C depicts an exploded view of an air circuit according to anexample of the present technology.

FIG. 37A depicts a perspective view of a vent adaptor according to anexample of the present technology.

FIG. 37B depicts another perspective view of a vent adaptor according toan example of the present technology.

FIG. 37C depicts a lateral view of a vent adaptor according to anexample of the present technology.

FIG. 37D depicts a cross-sectional view of a vent adaptor taken throughline 37D-37D of FIG. 37B according to an example of the presenttechnology.

FIG. 37E depicts an exploded view of a vent adaptor according to anexample of the present technology.

FIG. 38A depicts a perspective view of a heat and moisture exchanger(HME) housing according to an example of the present technology.

FIG. 38B depicts another perspective view of a HME housing according toan example of the present technology.

FIG. 38C depicts an exploded view of a HME housing according to anexample of the present technology.

FIG. 39A depicts a perspective view of a heat and moisture exchanger(HME) housing according to an example of the present technology.

FIG. 39B depicts another perspective view of a HME housing according toan example of the present technology.

FIG. 39C depicts an exploded view of a HME housing according to anexample of the present technology.

FIG. 40 depicts a perspective view of a vent adaptor with a patientinterface according to an example of the present technology.

FIG. 41 depicts a perspective view of a vent adaptor with a patientinterface according to an example of the present technology.

FIG. 42A shows a top perspective view of a vent housing according toanother example of the present technology.

FIG. 42B shows a top view of a vent housing according to another exampleof the present technology.

FIG. 42C shows a bottom view of a vent housing according to anotherexample of the present technology.

FIG. 42D shows a bottom perspective view of a vent housing according toanother example of the present technology.

FIG. 42E shows a side view of a vent housing according to anotherexample of the present technology.

FIG. 42F shows a cross-sectional view of a vent housing according toanother example of the present technology taken through line 42F-42F ofFIG. 42B.

FIG. 42G shows a cross-sectional view of a vent housing according toanother example of the present technology taken through line 42G-42G ofFIG. 42B.

FIG. 43A shows a top perspective view of a vent system according toanother example of the present technology.

FIG. 43B shows a top view of a vent system according to another exampleof the present technology.

FIG. 43C shows a bottom view of a vent system according to anotherexample of the present technology.

FIG. 43D shows a bottom perspective view of a vent system according toanother example of the present technology.

FIG. 43E shows a side view of a vent system according to another exampleof the present technology.

FIG. 43F shows a cross-sectional view of a vent system according toanother example of the present technology taken through line 43F-43F ofFIG. 43B.

FIG. 43G shows a cross-sectional view of a vent system according to anexample of the present technology taken through line 43G-43G of FIG.43B.

5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

The following description is provided in relation to various exampleswhich may share one or more common characteristics and/or features. Itis to be understood that one or more features of any one example may becombinable with one or more features of another example or otherexamples. In addition, any single feature or combination of features inany of the examples may constitute a further example.

5.1 Therapy

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

In certain examples of the present technology, a supply of air atpositive pressure is provided to the nasal passages of the patient viaone or both nares.

In certain examples of the present technology, mouth breathing islimited, restricted or prevented.

5.2 Treatment Systems

In one form, the present technology comprises an apparatus or device fortreating a respiratory disorder. The apparatus or device may comprise anRPT device 4000 for supplying pressurised air to the patient 1000 via anair circuit 4170 to a patient interface 3000.

5.3 Patient Interface

A non-invasive patient interface 3000 in accordance with one aspect ofthe present technology comprises the following functional aspects: aseal-forming structure 3100, a plenum chamber 3200, a positioning andstabilising structure 3300, a vent 3400, one form of connection port3600 for connection to air circuit 4170, and a forehead support 3700. Insome forms a functional aspect may be provided by one or more physicalcomponents. In some forms, one physical component may provide one ormore functional aspects. In use the seal-forming structure 3100 isarranged to surround an entrance to the airways of the patient so as tofacilitate the supply of air at positive pressure to the airways.

5.3.1 Seal-Forming Structure

In one form of the present technology, a seal-forming structure 3100provides a seal-forming surface, and may additionally provide acushioning function.

A seal-forming structure 3100 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In one form, the seal-forming structure 3100 comprises a sealing flangeand a support flange. The sealing flange comprises a relatively thinmember with a thickness of less than about 1 mm, for example about 0.25mm to about 0.45 mm, that extends around the perimeter of the plenumchamber 3200. Support flange may be relatively thicker than the sealingflange. The support flange is disposed between the sealing flange andthe marginal edge of the plenum chamber 3200, and extends at least partof the way around the perimeter. The support flange is or includes aspring-like element and functions to support the sealing flange frombuckling in use. In use the sealing flange can readily respond to systempressure in the plenum chamber 3200 acting on its underside to urge itinto tight sealing engagement with the face.

In one form the seal-forming portion of the non-invasive patientinterface 3000 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

Nasal pillows in accordance with an aspect of the present technologyinclude: a frusto-cone, at least a portion of which forms a seal on anunderside of the patient's nose, a stalk, a flexible region on theunderside of the frusto-cone and connecting the frusto-cone to thestalk. In addition, the structure to which the nasal pillow of thepresent technology is connected includes a flexible region adjacent thebase of the stalk. The flexible regions can act in concert to facilitatea universal joint structure that is accommodating of relative movementboth displacement and angular of the frusto-cone and the structure towhich the nasal pillow is connected. For example, the frusto-cone may beaxially displaced towards the structure to which the stalk is connected.

In one form, the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on a chin-region of thepatient's face.

5.3.2 Plenum Chamber

The plenum chamber 3200 has a perimeter that is shaped to becomplementary to the surface contour of the face of an average person inthe region where a seal will form in use. In use, a marginal edge of theplenum chamber 3200 is positioned in close proximity to an adjacentsurface of the face. Actual contact with the face is provided by theseal-forming structure 3100. The seal-forming structure 3100 may extendin use about the entire perimeter of the plenum chamber 3200.

5.3.3 Positioning and Stabilising Structure

The seal-forming structure 3100 of the patient interface 3000 of thepresent technology may be held in sealing position in use by thepositioning and stabilising structure 3300.

In one form of the present technology, a positioning and stabilisingstructure 3300 is provided that is configured in a manner consistentwith being worn by a patient while sleeping. In one example thepositioning and stabilising structure 3300 has a low profile, orcross-sectional thickness, to reduce the perceived or actual bulk of theapparatus. In one example, the positioning and stabilising structure3300 comprises at least one strap having a rectangular cross-section. Inone example the positioning and stabilising structure 3300 comprises atleast one flat strap.

In one form of the present technology, a positioning and stabilisingstructure 3300 comprises a strap constructed from a laminate of a fabricpatient-contacting layer, a foam inner layer and a fabric outer layer.In one form, the foam is porous to allow moisture, (e.g., sweat), topass through the strap. In one form, the fabric outer layer comprisesloop material to engage with a hook material portion.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap that is extensible, e.g.resiliently extensible. For example the strap may be configured in useto be in tension, and to direct a force to draw a cushion into sealingcontact with a portion of a patient's face. In an example the strap maybe configured as a tie.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap that is bendable and e.g.non-rigid. An advantage of this aspect is that the strap is morecomfortable for a patient to lie upon while the patient is sleeping.

5.3.4 Vent

In one form, the patient interface 3000 includes a vent 3400 constructedand arranged to allow for the washout of exhaled gases, e.g. carbondioxide.

One form of vent 3400 in accordance with the present technologycomprises a plurality of holes, for example, about 20 to about 80 holes,or about 40 to about 60 holes, or about 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Alternatively,the vent 3400 is located in a decoupling structure, e.g., a swivel.

5.3.5 Decoupling Structure(s)

In one form the patient interface 3000 includes at least one decouplingstructure, for example, a swivel or a ball and socket.

5.3.6 Connection Port

Connection port 3600 allows for connection to the air circuit 4170.

5.3.7 Forehead Support

In one form, the patient interface 3000 includes a forehead support3700.

5.3.8 Anti-Asphyxia Valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

5.3.9 Ports

In one form of the present technology, a patient interface 3000 includesone or more ports that allow access to the volume within the plenumchamber 3200. In one form this allows a clinician to supply supplementaloxygen. In one form, this allows for the direct measurement of aproperty of gases within the plenum chamber 3200, such as the pressure.

5.4 Vent Adaptor

5.4.1 Constant Flow Vent

FIG. 16 shows a comparison of vent flow rate between a regular vent (FFMNom Flow) versus the constant flow vent (CFV). The regular vent is astandard moulded vent, e.g., a vent 3400 formed on the patient interface3000 in FIG. 3A. As can be seen in the graph, the vent flow rate iscompared in a range of mask pressures between 4-20 cm of H2O, which is astandard pressure range for Respiratory Pressure Therapy for SDB andOSA. As can be seen, the vent flow rate increases logarithmically as thepressure increases. In comparison, the CFV shows a flatter curve, wherethe vent flow rate appears more constant and lower over the samepressure range.

Vent flow should be at least 16 L/min to washout enough CO2 within thesystem such that CO2 rebreathing is minimized by the patient. It hasbeen shown that a vent flow rate of between 20-27 L/min is providesbreathing comfort (patient not awakened due to increased CO2rebreathing) and safety (avoid suffocation due to too much CO2rebreathing). One aspect of the present technology includes providing aminimum (or minimum range) vent flow to ensure that sufficient CO2 iswashed out. Any vent flow above that minimum may be considered wastage.For example, when viewing the graph shown in FIG. 16 , the area betweenthe CFV vent flow and FFM Nom flow may be considered wasted flow. TheCFV achieves the minimum vent flow rate of 16 L/min required withintherapeutic pressure range and keeps this vent flow rate between 16-27L/min within the pressure range of 4-20 cm of H2O. In comparison, theFFM Nom flow ranges from 22-55 L/min. Thus, there may be greaterunnecessary flow loss using the FPM nom flow vent.

To compensate for unnecessary flow loss, the flow generator or RPTdevice may be required to increase its flow to achieve the same pressureas compared to the CFV. Thus, more power is required and a more complexflow generator is required to allow for greater flow swings (e.g.between 16-55 L/min of vent flow) to compensate for this vent. The CFV,however, may regulate the vent flow under pressure changes to reduce thevent flow rate as pressure increases. Thus, the CFV may allow forgreater power savings by the flow generator and added simplicity due toavoiding the need for complex pressure/flow control.

A constant flow vent (CFV), according to the present technology, may bea vent flow regulating valve (moveable membrane) 9140 that reacts tomask pressure to regulate vent flow. An exemplary CFV is depicted inFIGS. 21A-21F. The valve 9140 may be tuned such that the flow remainsrelatively constant within a predetermined range of pressure. That is,when pressure increases in the mask/system, the flap 9140 covers moreinternal vent holes 9126 to reduce the vent flow rate (vent flow rateincreases at higher pressures); when the pressure is low in themask/system, the flap 9140 covers fewer of the vent holes and allowsmore vent flow (compensates for low vent flow rates at lower pressures).This tuning may allow for a substantially constant vent flow within arange of pressures. The graph in FIG. 18 illustrates changes in flowunder changes in pressure with and without the CFV. The performance ofthe exemplary CFV graphed in FIG. 18 has a flow rate of up to 24 L/minas pressure increases from 0-40 cm H2O.

According to an example of the present technology, the CFV may comprisea moveable flap or a CFV membrane 9140 and may be made of elasticmaterial such as silicone or other TPE (thermoplastic elastomers). Theflap 9140 may be configured such that an increase in pressure in themask urges the flap to cover more of the internal vent holes 9126 andreduces the flow rate progressively. The flap 9140 may be positionedperpendicular to the flow of pressurized gas flowing to the patient. Thevent passage of the internal vent holes 9126 may also runperpendicularly to the flow and away from the patient to exit to theatmosphere. The flap 9140 is positioned such that pressure build up inthe mask may urge the flap towards the internal vent holes 9126.

FIG. 21F shows the configuration of an exemplary CFV in cross section.The CFV unit may be placed in line (that is within the air deliveryconduit circuit). As shown in FIG. 21F, if pressure builds up in themask then the position of the flap 9140 is such that the flap 9140 maymove towards the internal vent holes 9126. The pressurized gas thatreaches the internal vent holes 9126 that are not blocked by the flap9140 can then be vented to atmosphere via the external vent holes 9125.

The CFV is a feature that may allow for simplification of the RPTsystem. Having a substantially constant vent flow rate within a range ofpressures means that the complexity of the flow generator or RPT devicemay be reduced as substantial pressure control is no longer required tocompensate for changing pressure loss due to venting. Moreover, the CFVmay allow for reduced power consumption as power is no longer requiredto compensate for flow variations at different pressures. That is, theCFV is passively (pressure driven) and is capable of regulating pressuredue to vent flow changes that would otherwise be actively compensated bychanges in pressure/flow delivery from the RPT device. Thissimplification allows for a simpler RPT device to deliver therapy, e.g.,the device may have fewer parts, it may be smaller, it may not requirepowered humidification, and/or it may require less power overall todeliver therapy (due to the fact that it does not need to compensate forvent flow changes). The CFV may also allow for passive humidificationvia a heat and moisture exchanger (HME), as described below.

A problem with known CFV concepts is that there may be vent noiseassociated when regulating the vent flow. It is possible that there issome interaction with the flap 9140 and the internal vent holes 9126that disturbs vent flow and causes noise. For example, it ishypothesized that the moveable flap 9140 does not fully cover some ofthe internal vent holes 9126 when moving under pressure. Thisinteraction may cause turbulence and associated noise as gas flowsbetween the flap 9140 and the internal vent hole 9126.

One way to reduce turbulence and, therefore, noise may be to reduce thenumber of holes 9126 that interact with the flap 9140. However, aminimum vent flow is required to prevent CO2 rebreathing in the mask andreducing the number of vent holes 9126 that interact with the flap 9140may not allow sufficient venting. Thus, a solution according to thepresent technology may involve having some of the vent holes 9126 beingregulated by radial disc flap 9140 and other vent holes 9126 notengaging with the flap 9140 and remaining open at all times. Having somevent holes 9126 open, i.e., the static vents, at all times means thatthe vent flow rate will increase as pressure increases in the system,according to Bernoulli's principle.

To compensate for this increase in vent flow rate such that the overallvent flow is substantially constant over the therapeutic range ofpressures, the vent flow of the remaining vent holes, i.e., theregulated vents, may be reduced as pressure increases. These vent holes9126 may be regulated by the moveable flap 9140, wherein the vent holes9126 are covered progressively as the pressure increases, therebyreducing the vent flow rate. The overall flow rate of the static ventscan then be averaged with the flow rate of the regulated vents toachieve an overall substantially constant flow rate over a range oftherapeutic pressures. The lower noise levels of the vents can also beattributed to moulded vent technology that produces low levels of noiseas pressure and vent flow increases (e.g., by moulding small vent holeswith a converging profile). This technology in combination with theregulated vent flow may allow for a low overall noise alternative for aconstant flow vent.

A vent adaptor 9100 or fluid connector may comprise a constant flow vent(CFV) unit. The CFV unit may comprise: a CFV ring 9150; a flat, annularvalve 9140; and a vent housing 9120. The CFV ring 9150 may hold thevalve 9140 in place against the vent holes 9126. The vent housing 9120may comprise an annular surface comprising a plurality of vent holes9126. The annular surface may comprise a central orifice for allowingthe flow of pressurised gas into the mask chamber (inlet flow). Theannular surface may comprise the plurality of vent holes 9126 to allowvent flow. The valve 9140 may be adjacent to the vent holes 9126 and maybe held freely between i.e., sandwiched between, the CFV ring 9150 andthe annular surface of the vent housing 9120, i.e., the flap 9140 is notfixed to CFV ring 9150 or the vent housing 9120. As mask pressureincreases, this increases pressure towards the vent, wherein the valve9140 is pushed towards and covers more of the vent holes 9126. Incontrast, as mask pressure decreases, less pressure is applied to thevalve 9140, thus the valve 9140 moves away from and covers less of thevent holes 9126.

Reducing the vent noise for the constant flow vent design may beaccomplished by altering the vent flow characteristics by the use of aflow regulating valve or membrane 9140. However, the membrane 9140 mayincrease vent noise over traditional moulded or static vents, i.e., thevent holes do not change form or shape during changes in pressure. Thisnoise may be attributed to a number of factors, including: 1) the changeof the velocity of flow through the regulated vents as the vent holes9126 are opened or closed by the membrane 9140 and/or 2) flowdisturbances caused by the membrane 9140 that generate noise, i.e.,turbulence. For example, changing the direction of vent flow can causeturbulence, which may then result in noise from a number of factors.This can be caused by gases colliding into the surfaces of the vent(vent walls or CFV membrane) 9140, or air passing over the surface ofthe vent (vent walls and/or membrane) 9140. Thus, partially closing ventholes 9126 can generate more noise due to factors 1) and/or 2) above.

As mentioned above, an aspect of the present technology includes a ventwith a substantially constant flow within a therapeutic pressure range(i.e., 4-20 cm H2O, or 2-40 cm H2O). To meet the desired vent flow curveunder pressure changes, the vent holes' 9126 flow curve may be varieddynamically over the therapeutic pressure range. This may beaccomplished by changing the size, number, and/or shape of the ventholes. Varying such characteristics may lead to changes in flowcharacteristics of gases passing through the vent holes, which can leadto an increase in vent noise. Using moulded vent technology thatincludes a converging vent hole shape as gases exit the vent into theatmosphere, i.e., converging from the internal vent holes 9126 to theexternal vent holes 9125, noise of the vent flow may be tuned to aminimum. However, it should be understood that moulded vent holes do notchange size, shape, or number under pressure changes. Accordingly,deformable membranes or flaps 9140 that move under pressure to close offor open vents may be used to vary the flow through the vent holes 9126.Deformable membranes or flaps 9140, however, may generate undesirablenoise levels due to the change of the velocity of flow through theregulated vents as the vent holes 9126 are opened or closed by themembrane 9140 and/or by having partially closed vent holes 9126.

It may be possible to reduce such noise by including membrane flaps 9140that progressively close off vent holes 9126 as pressure increases,wherein the flap(s) 9140 is fixed on one end such that the flap 9140deflects under pressure changes. A problem with this technology is thatthe membrane 9140 may only partially close off a given vent hole 9126,which can lead to flow passing between the vent hole 9126 and membrane9140 at high velocities. This, in turn, generates noise as air passesalong the surface of the vent holes 9126 and membrane 9140 or collidesinto these surfaces.

It is possible to overcome this issue by reducing the number ofregulated vent holes, while maintaining an overall substantiallyconstant vent flow within the therapeutic pressure range to reduce ventnoise. A desired noise levels can be maintained using moulded vent holes(i.e., static vents). These vent holes, however, may not be able achievethe desired flow curve (i.e., a substantially constant flow rate over atherapeutic pressure range between 4-20 cm H2O). This may be achieved bycombining some regulated vent holes with static vent holes, such thatthe overall vent flow is substantially constant over a therapeuticpressure range. Increasing the number of static vents, which are notregulated by a membrane, may result in a reduction in overall ventnoise.

This introduction of moulded vent holes, however, may introduce a newproblem, whereby it may be difficult to ensure a substantially constantvent flow within the therapeutic pressure range using a combination ofstatic vents and regulated vents. It is known, as shown in FIG. 16 ,that the vent flow characteristics of moulded static vent holes is alogarithmic curve where vent flow increases as pressure increases. Tocompensate for the flow of the static vents, the regulated vents shouldprovide an inverse flow curve where vent flow decreases as pressureincreases. Thus, the membrane 9140 regulating the vent holes 9126 may betuned to provide such a vent flow.

There are a number of ways to tune the membrane 9140 to provide a ventflow that is inverse to the logarithmic flow curve of the static,moulded vents. For example, the shape/structure of the membrane 9140 maybe changed to tune the flow curve of the regulated vents and thematerial of the membrane 9140 may be changed to tune the flow curve ofthe regulated vents.

An annular disc membrane 9140 structure of the CFV membrane, as shown inFIG. 20 , may allow the membrane 9140 to be tuned in a number of wayssuch that it changes the regulated vent flow. The regulated vent flowmay be altered by how much of the vent holes 9126 are covered/openedunder a fixed pressure. A membrane 9140 that covers more of the ventsunder a fixed pressure would have a lower vent flow than one that coversless. The annular disc structure 9140 may allow for the membrane 9140 tobe readily tuned to cover varying amounts of the vents under a fixedpressure. One way this may be done is by changing the diameter of thecentral orifice or by changing the width of the vent engaging surface.

The overall size of the membrane 9140 is restricted by the size of theCFV unit housing 9120, however, it is desirable to reduce the size ofthe CFV as much as possible. Thus, the width of the vent hole engagingsurface may be adjusted by adjusting the size of the central orifice. Anincrease in the size of the central orifice results in the width of thevent hole engaging surface to also be reduced. This reduction in width,in turn, results in a reduction in surface area of the membrane 9140.The reduction in surface area means there is less resistance todeformation under a fixed pressure, whereby more of the vent holes arecovered at the fixed pressure compared to a wider membrane 9140 (i.e.,more surface area). This principle holds true within a predeterminedrange of surface area. That is, if the surface area is too low such thatthere is not enough surface (i.e., width of the vent hole engagingsurface is too low), then more force is required to deform the membrane9140 (i.e., it bottoms out).

The membrane 9140 thickness may also be varied such that it deforms morereadily under a fixed pressure. For example, a thinner membrane 9140would more readily deform under a mask pressure of 15 cm H2O whencompared to a thicker membrane 9140 of the same shape at the samepressure.

The membrane 9140 may also be structured such that it freely moves tocover the vent holes 9126 under a fixed pressure. For example, inrelated technologies, the membrane 9140 may be fixed at a point, e.g.,on the vent housing 9120 such that it is hinged relative to the fixedpoint and the membrane 9140 would be deflected about the fixed point dueto pressure changes.

The design of the CFV membrane 9140 according to an example of thepresent technology allows it to freely move between a retainingstructure and a vent hole surface. This configuration may allow themembrane 9140 to be more easily tuned to adjust the vent flow whencompared to a flap design, i.e., where the membrane is fixed on one endand moves relative to the fixed end.

A membrane 9140 that is more flexible/compliant may deform more readilyunder a fixed pressure/load, thereby covering more of the vent holes9126 in comparison to a stiffer membrane. Thus, changing the material ofa membrane 9140, while otherwise having the same size and structure, toa more flexible material will allow the membrane 9140 to deform morereadily under the same pressure to cover more of the vent holes 9126 andreduce vent flow. Thus, this may allow tuning the membrane 9140 toprovide the desired vent flow curve within the therapeutic pressurerange.

A number of ways, as mentioned above, can be used to provide a membrane9140 that responds to pressure within the targeted therapeutic range toprovide a predetermined vent flow curve, i.e., an overall substantiallyconstant vent flow rate between the pressures of 4-30 cm of H2O. It alsomay be desired to provide such a constant vent flow while minimizingvent noise, one solution may be to maximize the number of staticnon-membrane regulated vents and have the minimum number of membraneregulated vents that provide an average total vent flow that issubstantially constant. This flow curve is shown by the thicker, solidline entitled “Passive vent only” in FIG. 19 . In this example, thedashed line represents the static, non-membrane regulated vents, whilethe thinner, solid line entitled “Combination of the CFV & passivevents” represents the combined vent flow. It is notable that the ventflow of the static vents progressively increases as pressure increases,while the CFV membrane regulated vents progressively decreases to athreshold.

Another cause of noise may be attributed to vent flow disturbancescaused by the CFV membrane 9140 that may also impact the flow of airflowing through the static vents. In a related technology, the staticvents were positioned proximal to the CFV membrane regulated vents,i.e., the vent holes were positioned on the same surface of the CFVhousing 9120. This led to noise being generated even for thenon-regulated static vents as the membrane had impact on the flowcharacteristics of the static vent flow. Thus, it may be desirable toposition the static vents away from the CFV membrane regulated ventssuch that the membrane 9140 does not impact the static vent flowtherethrough. In an example of the present technology, the static ventholes are positioned on a distal surface from the CFV regulated ventholes. For example, the static vent holes may be positioned on adifferent component than the CFV housing 9120. The positioning of thestatic vents may be restricted in that they may not be able to wash outCO2 as well. The ability to washout CO2 increases as the static ventholes are positioned closer to the patient. However, the static ventholes may also be positioned on an opposing side of the HMX relative tothe patient to prevent loss of moisture during exhalation, as explainedbelow.

5.4.1.1 Vent Housing

FIGS. 42A to 42G depict examples of a vent system 13400 according to anexample of the present technology. The vent system 13400 includes a venthousing 13401 that may include an outer wall 13402 and the outer wall13402 may define the outer periphery of the vent housing 13401. The venthousing 13401 may also include an inner wall 13410 that may define aninlet for the flow of gas generated by the RPT device 4000 and directedinto the plenum chamber 3200 and toward the patient for therapy. As canbe seen, the outer wall 13402 and the inner wall 13410 are formed asconcentric circles in this example.

Positioned between the outer wall 13402 and the inner wall 13410 is abase. The base may further comprise an outer base 13403 and an innerbase 13406. The outer base 13403 may extend from the inner periphery ofthe outer wall 13402 and the inner base 13406 may extend from the outerperiphery of the inner wall 13410. As can be seen, the outer base 13403and the inner base 13406 are also formed as concentric circles in thisexample.

The outer base 13403 may include one or more outer orifices 13404distributed radially around the outer base 13403. These outer orifices13404 may extend entirely through the outer base 13403 to provide a flowpath from the interior of the vent system 13400 to atmosphere. The outerorifices 13404 may be straight, i.e., perpendicular to the outer base13403, or the outer orifices 13404 may pass through the outer base 13403with a curved path or a slanted path. The diameter of the outer orifices13404 may be constant along their length or the diameter may be varied.The outer orifices 13404 may all be identical or some may be differentfrom others. The edges of the outer orifices 13404 may have a chamfer ora fillet. The outer base 13403 may at least partially support themembrane 13430 to prevent the membrane 13430 from completely occludingthe inner orifices 13407. Accordingly, the outer base 13403 may extendhigher up than the inner base 13406, as can be seen in FIGS. 42A to 42G.

The vent housing 13401 may also include lateral membrane supports 13405distributed about the outer base 13403 and the inner periphery of theouter wall 13402. The lateral membrane supports 13405 may abut andprevent the membrane 13430 from moving laterally during use, therebycovering the outer orifices 13404. As will be explained below, it may bedesirable not to obstruct the outer orifices 13404 so that the ventsystem 13400 will be able to maintain a substantially constant vent flowrate over a large proportion of the range of typical therapeuticpressures. Therefore, the lateral membrane support 13405 may protruderadially inward beyond the edges of the outer orifices 13404. Thelateral membrane supports 13405 may be semi-circular, as in FIGS. 42A to42G. In the examples depicted in FIGS. 42A to 42G, the outer orifices13404 are distributed evenly in groups of three between adjacent lateralmembrane supports 13405 about the circumference of the outer base 13403.

The vent housing 13401 may also have a circular shape. However, the venthousing 13401 may also be shaped elliptically or the vent housing 13401may have a polygonal shape, such as a triangle, a square, a rectangle, apentagon, a hexagon, etc. In any of these configurations, the membrane13430 may be shaped to correspond with the shape of the vent housing13401.

The inner base 13406 may be positioned radially inward of the outer base13403 and the inner base 13406 and the outer base 13403 may be joined bybase connectors 13408 distributed radially therebetween. Betweenadjacent base connectors 13408 and between the inner base 13406 and theouter base 13403 there are one or more inner orifices 13407. The innerorifices 13407 in these examples are shaped as slots with an arc-shapedcross-section. However, it is envisioned that the inner orifices 13407may be circular holes, similar to the outer orifices 13404. The innerorifices 13407 extend completely through the vent housing 13401 betweenthe inner base 13406 and the outer base 13403. As will be explainedbelow, it may be desirable to allow the inner orifices 3407 to be atleast partially obstructed by the membrane 13430 to allow the ventsystem 13400 to maintain a substantially constant vent flow rate over alarge proportion of the range of typical therapeutic pressures. Theedges of the inner orifices 13407 may have a chamfer or a fillet.

The inner base 13406 of the vent housing 13401 may also include severalmembrane spacers 13409. The membrane spacers 13409 may be evenlydistributed radially about the inner base 13406. As shown in FIGS. 42Ato 42G, the membrane spacers 13409 may be located on the edge of theinner base 13406 so as to fade into the inner wall 13410. The membranespacers 13409 are provided to at least partially support the membrane13430, as will be described in greater detail below. The membranespacers 13409 may extend from the inner base 13406 in a semi-cylindricalshape or in a rectangular shape, as in FIGS. 42A to 42G. The edges ofthe membrane spacers 13409 may have a chamfer or a fillet.

The vent housing 13401 may also include one or more recesses 13415spaced around the opposite side of the outer base, as can be seen inFIGS. 42A to 42G. The recesses 13415 may be separated by recess dividers13414. The outer orifices 13404 may extend through the outer base 13403and open into the corresponding recesses 13415 and multiple outerorifices 13404 may open into a single recess 13415.

In an alternative example, the vent housing 13401 may only include onegroup of orifices that are analogous to the inner orifices 13407described above in that the vent flow passing therethrough can berestricted by the membrane's 13430 position. Accordingly, there may alsobe another group of orifices provided elsewhere on the patient interface3000 that are analogous to the outer orifices 13404 described above inthat the vent flow passing therethrough is not restricted by themembrane 13430, regardless of the membrane's 13430 position. The lattergroup of orifices that are not restricted by the membrane 13430 may beplaced on any of the plenum chamber 3200, the seal-forming structure3100, the decoupling structure 3500, the vent connector tube 4180, orother component that is closer to the patient than the vent housing13401. It is envisioned that the principles of operation of the ventsystems 13400 described above will apply to such an alternativearrangement, but the ability to locate the orifices that are notrestricted by the membrane 13430 closer to the patient may improve thedischarge of exhaled CO2.

The vent housing 13401 may be made from a single, homogeneous piece ofmaterial. The material of the vent housing 13401 may be relativelyrigid. The material of the vent housing 13401 may be polycarbonate.

5.4.1.2 Membrane

FIGS. 43A to 43G also depict views of an exemplary membrane 13430 withthe vent system 13400 and positioned adjacent to the vent housing 13401.The exemplary membrane 13430 may be used with any of the various venthousing 13401 configurations disclosed above. The membrane 13430 may bein the shape of a flat, circular disk. In other words, the thickness ofthe membrane 13430 (see FIGS. 43F and 43G) may be small relative to itsouter diameter. The thickness of the membrane 13430 may be uniformthroughout, as shown in FIGS. 43F and 43G. Alternatively, the thicknessof the membrane 13430 may be variable in a radial direction.

The membrane 13430 includes a membrane opening 13431 such that whenassembled onto the vent housing 13401, the flow of air through the inlet13411 also passes through the membrane opening 13431 and along to thepatient. The membrane 13430 also includes a patient-side surface 13432that faces towards the patient in use and an atmosphere-side surface13433 opposite the patient-side surface 13432 that faces towards theatmosphere in use. Additionally, the atmosphere-side surface 13433 facestowards the vent housing 13401 when assembled. The membrane 13430 alsoincludes an inner surface 13434 that defines the membrane opening 13431and an outer surface 13435 that is opposite the inner surface 13434.

The inner radius, i.e., the radius of the inner surface 13434, and theouter radius, i.e., the radius of the outer surface 13435, may beselected such that the membrane 13430 can be located over the innerorifices 13407 in use without covering the outer orifices 13404. Also,the inner radius and the outer radius may be selected such that themembrane 13430 covers a substantial portion of the inner base 13406while being supported on the membrane spacers 13409 proximal to theinner surface 13434 and on the outer base 13403.

The membrane 13430 may be made from a single piece of homogeneousmaterial. The material maybe elastically deformable such that themembrane 13430 can be deflected in use by the pressure from the flow ofair. The material may be silicone. The membrane 13430 may be “tuned” todeform in a desired manner by altering one or more of its thickness,length, material, shape, inner radius, and/or outer radius.

5.4.1.3 Constant Flow Rate Vent System

FIGS. 43A to 43G depict several views of exemplary vent systems 13400with the membrane 13430 assembled with the vent housing 13401. In FIGS.43A to 43G, the inner wall 13410 does not extend above the inner base13406. In the examples where the inner wall 13410 extends upward fromthe inner base 13406, the inner wall 13410 may provide a baffle functionthat separates the flow of gas traveling into the vent system 13400 viathe inlet 13411 from the vent flow exiting the vent system 13400, whichin turn may reduce the amount of flow traveling in from the inlet 13411and then directly out of the vent system 13400.

In the examples of FIGS. 43A to 43G, a portion of the membrane 13430proximal to the outer surface 13435 can be seen supported on an innerportion of the outer base 13403. Also, a portion of the membrane 13430proximal to the inner surface 3434 can be seen supported just above themembrane spacers 13409. However, the membrane 13430 may deform towardsthe membrane spacers 13409 by virtue of its own weight such that themembrane 13430 is also supported on the membrane spacers 13409 eventhough there may not be any air pressure causing the deformation.

FIGS. 43A to 43G also show the membrane's 13430 location constrained bythe lateral membrane supports 13405. As explained above, the membrane13430 may be shaped and dimensioned to cover only the inner orifices13407 and not the outer orifices 13404. However, the membrane 13430 maynot be directly attached to the vent housing 13401 and, as such, may befree to move. Therefore, a sufficient number of lateral membranesupports 13405 can prevent lateral movement of the membrane 13430 sothat the membrane 13430 cannot cover one or more of outer orifices 13404in use.

The inverse of these examples is also envisioned in which the outerorifices 13404 may be covered by the membrane 13430 and the innerorifices 13407 are not blocked by the membrane 13430. Accordingly,lateral membrane supports 13405 may be provided to prevent the membrane13430 from covering the inner orifices 13407.

As explained above, the exemplary vent systems 13400 may include amembrane 13430 positioned over the inner orifices 13407 to at leastpartially restrict the flow of gas through the inner orifices 13407,while the vent flow through the outer orifices 13404 is not restrictedby the membrane 13430.

It should also be understood that the features of the vent system 13400described in sections 5.4.1.1 to 5.4.1.3 may be incorporated into any ofthe vent adaptors 9100 disclosed in section 5.4.5.

5.4.2 Vent Diffuser

The vent adaptor 9100 may also comprise a portion for housing a diffuser9146. The diffuser 9146 may be removable for replacement. The diffuser9146 may have an annular disc shape that complements the shape of theannular surface of the vent housing 9120 on the side facing theatmosphere, i.e., external to the inlet flow. The diffuser 9146 maycover the vent holes 9125 and may diffuse the vent flow after it exitsthe plurality of vent holes 9125. That is, the vent flow flowing throughmoulded vent holes 9125 may flow through the diffuser 9146 prior toreaching the atmosphere.

The diffuser 9146 may also act as a sound absorbent material to reducesome of the noise generated by the CFV membrane 9140 regulated andstatic vents.

FIG. 26 illustrates a cross-section through some of the orifices 3402.The orifices 3402 are illustrated as holes through a wall 3404 of theplenum chamber 3200. However, the orifices 3402 may be located inlocations other than the wall 3404. For example, the orifices 3402 maybe located between the decoupling structure 3500 and the connection port3600 or in a portion of the air circuit 4170, preferably near theconnection port 3600 or in the vent adaptor 9100. The holes areillustrated with a diameter that is smaller than an axial length of thehole. The length and/or diameter may be chosen so that an appropriateflow rate is generated when the plenum chamber 3200 is pressurized tothe therapy pressure. The flow through the orifices 3402 may be choked(e.g. a Mach number of 1) at the therapy pressure (e.g. at 4 cmH₂O orgreater pressure) or the flow may generate less than sufficient pressuredrop to be choked. A choked flow may result in substantially all of thepressure drop in the vent 3400 being caused by the orifices 3402. Thearrows conceptually illustrate direction of flow when the plenum chamber3200 is pressurized above ambient pressure.

The orifices 3402 are formed through a thickness of material of the wall3404. Each of the orifices 3402 defines an axis, e.g., along a center ofthe orifice. The axis forms an acute angle with a normal to a surface ofthe wall 3404. The angle may be between 15 and 75 degrees or between 30and 60 degrees, including any integer within the stated ranges. Forexample, the angle may be about 45 degrees.

The orifices 3402 are covered by a diffusing member 3406 so that flowexiting the orifices 3402 impinges on and flows at least partially intothe diffusing member 3406. The diffusing member 3406 may be formed froma material, such as a porous material, that allows gas to flow throughthe material but diffuses any jet or other flow formation exiting theorifices 3402. Some suitable examples of diffusing material include anon-woven fibrous material; a woven fibrous material; or an open cellfoam material. The diffusing material may be similar to or the same as afilter media. The diffusing member 3406 may reduce perceptible noisegenerated by the vent 3400 in use (e.g., when therapy pressure isapplied).

The diffusing member 3406 is illustrated as covered by a blocking member3408 that prevents gas from flowing out of the orifices 3402 anddirectly through the diffusing member 3406. The blocking member 3408 maybe constructed, at least in part, from an air-impermeable material. Theair-impermeable material may be any suitable flexible or rigid material.For example, the air-impermeable material may be a rigid plastic (e.g.,molded polycarbonate) or a flexible plastic (e.g., a plasticcommercially available in sheet form). The blocking member 3408 may beformed integrally with the diffusing member 3406, formed separately butpermanently affixed to the diffusing member 3406, formed separately andin removable contact with the diffusing member 3406, or combinationsthereof. The blocking member 3408 is illustrated as opposite the outletorifices 3402 with respect to a thickness of the diffusing member 3406.

The blocking member may cause the flow to change direction (with respectto the direction through the orifices 3402) before exiting the diffusingmember 3406. The blocking member 3408 and/or diffusing member 3406 maybe configured so that flow out of the orifices 3402 must flow at least apredetermined distance through the diffusing member 3406 prior toexiting to ambient atmosphere. The blocking member 3408 may also beconfigured to provide a particular direction and/or orientation for flowexiting the vent 3400 to minimize any disturbance to the wearer and/orbed partner caused by the flow. For example, the blocking member 3408may cause gas to flow through the diffusing member 3406 and generallyparallel to a surface of blocking member 3408 nearest to the diffusingmember 3406.

In FIG. 26 , the orifices 3402 and the diffusing member 3406 areoriented relative to one another such that a central axis of each of theorifices is not perpendicular to a nearest surface of the diffusingmember 3406, although a perpendicular arrangement could also be providedas illustrated in FIG. 8 .

Channels 3410 may also be provided on an outer surface of the wall 3404.The channels 3410 are illustrated with a V-shaped cross-section butcould be formed with any suitable cross-section such as a U-shape. Thechannels 3410 may be configured to allow liquid to drain away from oneor more outlets of the orifices 3402. The orifices 3402 may be formed ina leg of the V-shape or U-shape.

FIG. 27 illustrates an alternate configuration of the blocking member3408. In FIG. 27 , the blocking member 3408 includes holes 3412. Theholes 3412 may direct the flow out of the diffusing member 3406 on theopposite side from the orifices 3402 but in a different direction. Thusthe flow path is not straight through the orifices 3402 and thediffusing member 3406. Although the arrows associated with the holes3412 are illustrated parallel, this is for ease of illustration only.The holes 3412 may be configured to redirect the flow in multipledirections.

The holes 3412 each define an axis that is neither aligned with norparallel to an axis defined by each of the orifices 3402. When viewed inthe cross-section of FIG. 27 , any one axis defined by a hole 3412 andany one axis defined by an orifice 3402 forms an angle. The angle may bebetween 15 and 75 degrees or between 30 and 60 degrees, including anyinteger within the stated ranges. For example, the angle may be about 45degrees.

FIGS. 28-30 illustrates an alternate configuration of the vent 3400.FIG. 28 illustrates a partially exploded view, FIG. 29 illustrates asimplified assembled view and FIG. 30 illustrates a cross-sectional viewtaken along line 30-30 of FIG. 29 . In these figures, the orifices 3402are illustrated in a circular array around a central hole 3414. Thecircular array is illustrated to include three circular rows of holeswhere the two inner-most circular rows are closer together than theouter-most circular row, but any number of circular rows may be providedan spacing between the rows may be equal. The central hole 3414 allowsfor fluid communication between the plenum chamber 3200 and theconnection port 3600 and thus the air circuit 4170. The diffusing member3406 and the blocking member 3408 are also illustrated as being disposedaround the central hole 3414. With this configuration, the blockingmember 3408 may be removably attached (e.g., a removable snap fit orthreaded engagement) or fixedly attached (e.g., permanent adhesive or asnap fit that must be broken to disassemble) and the diffusing member3406 may be fixed to the blocking member 3408 or not fixed to butretained by the blocking member 3408. As best viewed in FIG. 29 , radialopenings 3416 are provided for gas to escape the diffusing member 3406radially outward from the central hole 3414.

FIGS. 31A to 31C illustrate another alternate configuration of the vent3400. FIG. 31A illustrates a partial view of a flow passage in the formof an elbow 3418, which may be disposed between a decoupling structure3500 and connection port 3600, and includes a vent 3400. Thisconfiguration largely conceals the features of the vent 3400 and thusthe remaining description is with respect to FIGS. 31B and 9C.

FIG. 31B illustrates an axial view with the cap 3422 and diffusingmember 3406 omitted. This provides a clear view of the outlet orifices3402. Two annular rows, each including forty of the outlet orifices 3402are illustrated. The orifices are offset so that the outlet orifices3402 in the inner row and the outer row are not radially aligned. Thisconfiguration may allow for annular rows to have closer radial spacing.Although two rows are illustrated, any number of rows may be provided,for example one row or three or more rows. Although forty outletorifices 3402 are illustrated in each annular row, more or less may beprovided as required to maintain appropriate levels of gas washout. Forexample, one, five, ten, fifteen, twenty, twenty five, thirty, thirtyfive, forty, forty five, fifty or more outlet orifices 3402, or anynumber in between, may be provided per annular row.

In FIG. 31C, the annular array of orifices 3402 are visible in thecross-section through a wall 3420. The wall 3420 is similar to wall 3404except that the wall 3420 is illustrated remote from the plenum chamber3200; however, the wall 3420 may be part of the plenum chamber 3200.

The diffusing member 3406 is illustrated as a ring-shape with arectangular cross-section. The blocking member 3408 is illustrated as arelatively thin, sheet-like ring on a side of the diffusing member 3406opposite the orifices 3402. The blocking member 3408 may be affixed tothe diffusing member 3406 by any suitable means, for example byadhesive.

A cap 3422 is illustrated covering the diffusing member 3406 and theblocking member 3408. The cap 3422 may be in contact with the blockingmember 3408 such that the diffusing member 3406 is compressed againstthe wall 3420. Alternatively, the diffusing member 3406 may not becompressed against the wall 3420. The cap 3422 may serve as the blockingmember 3408, in which case the ring-shaped blocking member 3408illustrated in FIG. 31C may be omitted.

The cap 3422 may include an angled, annular flange 3424 that may bespaced away from the wall 3420 to form an annular gap 3426. The annularflange 3424 may also be considered skirt-like or frusto-connical. Theannular gap 3426 may provide a flow path to ambient atmosphere such thatthe flow of gas washout is not overly restricted. Alternatively, one ormore openings (such as radial opening 3416) may be provided in theannular flange 3424 to provide a flow path to ambient atmosphere, whichmay also allow for elimination, in whole or in part, of the annular gap3426.

The cap 3422 is illustrated with an annular groove 3428 mated with anannular protrusion 3430 to hold the cap 3422 in place. The annularprotrusion may be continuous to form a snap fit or may be multiple,annularly spaced annular protrusions to provide a configuration thatallows for minimal or no interference upon axial insertion followed by atwist to provide axial interference and hold the cap 3422 in place. InFIG. 31C, the annular protrusion 3430 is illustrated as three annularlyspaced annular protrusions. A lip 3432 of the annular groove 3428 may beomitted in three corresponding locations and sizes to provide forreduced or no interference of the cap 3422 during the axial insertion.Other forms of attachment are possible. For example, a threadedfastening arrangement may be provided, the cap 3422 may be held in placewith adhesive or welding. Releasable fastening such as the illustratedconfiguration or a threaded connection may allow for the diffusingmember 3406 to be replaced if, for example, the diffusing member becomesdamaged, clogged or dirty.

Although the vent 3400 is illustrated on one side of the bend (e.g.,upstream with respect to an exhalation direction) in the elbow 3418, thevent 3400 may be upstream or downstream of the bend.

FIGS. 32A to 32C illustrate another alternate configuration of the vent3400. Like reference numbers are similar to those described above andthus further description is omitted except as noted below. The vent 3400in these figures is formed around an example of the decoupling structure3500 that includes a ball 3434 and socket 3436 that are part of an elbow3418. In the form illustrated here, the ball 3434 and socket 3436 allowthree degrees of rotational freedom. However, fewer degrees ofrotational freedom are possible, e.g., one or two degrees of rotationalfreedom.

As best viewed in FIG. 32D, the cap 3422 is connected by way of a snapfit connection 3438 with a first half 3440 located on the cap 3422 and asecond half 3442 on the mating component. Six each of the first half3440 and second half 3442 are provided between six of the radialopenings 3416, three of which are visible in FIG. 32A. However, more orless may be provided as necessary to provide adequate retention and/orflow rate.

As best seen in FIG. 32C, forty-four orifices 3402 are illustratedequally spaced in a single annular row. However, the number and spacingof the orifices 3402 may take other configurations. For example, fewerorifices 3402 may be provided if, for example, lower flow rate isrequired or more orifices 3402 may be provided if, for example, greaterflow rate is required. And as explained above, more rows may beprovided. Also, the orifices need not be in an annular array. If, forexample, the orifices are located other than in the illustratedlocation, the orifices may be arranged in a grid based on Cartesiancoordinates. Alternatively, the orifices 3402 need not be in any type ofrow and may be located in random or pseudo random locations.

5.4.3 Heat and Moisture Exchanger (HME)

Heat and moisture exchangers (HMEs) may comprise materials that havewater retaining properties. Respiratory pressure therapy (RPT) canresult in drying of the airways causing breathing discomfort inpatients. To prevent this, a humidifier may be used in conjunction witha respiratory pressure device to deliver humidified air to the patient.This added humidifier may increases the size and power requirements ofRPT devices.

It is known that patient's generate a level of humidified air uponexhalation, which comes from the mucosa of the airways. HMEs can be usedto recycle this exhaled moisture by capturing humidity from humidifiedair upon exhalation then redelivering this to the patient. One challengein the use of HMEs is their efficacy (i.e., being able to capture enoughheat and moisture) and their impact on therapy (i.e., the HME may beplaced in the flow circuit and therefore cause flow impedance).

To improve efficacy, an aspect is to reduce any losses of heat andmoisture that is captured by the HME. A problem with the use of HMEs inRPT may be that heat and moisture expired by the patient is lost throughventing prior to reaching the HME. In order to minimize such losses, theHME may be placed proximal to the patient's airways (i.e., the source ofhumidity) and place the vent on an opposing side of the HME, i.e., awayfrom the patient. This configuration may ensure that expired humidifiedgases flow through the HME such that moisture is captured by the HMEprior to exiting through the vent. The vent adaptor may be configuredsuch that the HME is positioned between the patient's airways and theconstant flow vent.

The vent adaptor may also comprises an HME unit that is removable. Thatis, the vent adaptor can be used with or without the HME. The HME unitmay comprises a housing that holds the HME is place. The housing can beopened (the housing may comprises a front and rear component) to removethe HME.

The HME may be designed to maximize surface area per unit volume forheat and moisture exchange. In addition, the HME may also be designed todecrease its impact on flow impedance. The design may comprises aplurality of corrugations to allow flow to pass through saidcorrugations. The HME may be formed as a coiled layer of HME materialcomprising the corrugations.

As described above, the CFV may reduce flow wastage by regulating ventflow to a level that is above but close to the minimum required ventflow rate. As flow wastage is reduced, the level of humidity loss in thetherapy system may also be reduced. It is known in the art that patientsexpire humidified air, which may in turn cause drying of the mucosa.Applying RPT treatment for SDB may exacerbate this drying. Thus,reducing the amount of flow required to achieve therapeutic pressure andconcurrently reducing the level of humidified air loss from the systemmay result in a reduction of mucosal drying.

One way to increase the level of humidified air delivered to the patientis by the use of a powered humidification. Another way to humidify theair delivered to the patient is by the use of heat and moistureexchangers (HME), which capture the water vapours in air such that theymay be delivered back to the patient. An HME can be utilized to capturethe humidity from patient expiration, which in turn can redeliver thishumidity back to the patient. The HME should be positioned that itcaptures enough humidity from expired gas flow, as shown in FIG. 17 ,but allows this humidity to be redelivered through therapy flow. Toensure that captured humidity from expired gas flow is maximized, theHME should be placed between the patient and the vent. If the vent wereto be placed between the patient and the HME, it would lead to thehumidity in the expired gas flow being vented prior to reaching the HMEfor capture and redelivery. However, the configuration shown in FIG. 17can also result in humidity being lost through venting via therapy flowgoing through the HME then directly out the vent (prior to patientdelivery). This flow has been labelled “HME vent flow” in FIG. 17 . TheHME vent flow becomes more of an issue when the flow rate of the therapyincreases. As shown in the graph in FIG. 18 , the flow rate may increaseas mask pressure increases. This flow may be increased to compensate forvent flow losses. When the flow rate increases, the velocity of thetherapy flow increases, which may cause the therapy flow to penetratethe HME deeper. Some of this penetrating flow is delivered to thepatient, however, a portion of this flow may also be directed to thevent prior to patient delivery (as shown by the HME vent flow).Therefore, the HME vent flow may also result in humidity losses bydrying the HME.

As shown in the graph in FIG. 18 , the CFV may reduce the vent flow rateover the same pressure range as compared to the standard FFM nom flowvent. This reduction in flow may reduce the HME vent flow, therebyreducing humidity losses. In other words, less flow occurs at the samepressures in the CFV system when compared to the standard vent system,consequently reducing the HME vent flow. This reduction in HME vent flowenhances the capability of the HME to capture and redeliver humidityfrom the expired gas flow thereby synergistically enhancing the HMEeffect to reduce mucosal drying.

Another way of reducing the HME vent flow may be to redirect the flowdirection such that less flow passes through the vent and is redirectedback into the system. The redirection can be achieved by structures,e.g., baffles, positioned in the flow path between the HME and the ventsuch that less flow is directed out the vent into the atmosphere.

The present technology is capable of achieving near poweredhumidification levels without the use of powered humidification. Sincepowered humidification is no longer required, the flow generator may besimplified further, because it no longer requires a water reservoir andheating mechanism to deliver powered humidification to therapy flow.Therefore, both the CFV and the HME may allow a flow generatorassociated with the present technology to be effective in providing RPTtreatment for OSA and other SDB, without the need to complexpressure/flow control and powered humidification, which may ultimatelybenefit the patient by providing a substantially smaller flow generatorwith less controls.

FIGS. 25A to 25D show examples of a HME according to the presenttechnology. FIG. 25A shows a cross section of a HME 7000 comprising acorrugated structure 7002 comprising a plurality of corrugations 7030between a substantially planar substrate top structure 7010 and asubstantially planar substrate base structure 7020 to form a concertinalayer 7001. The layer 7001 comprises a plurality of superior channels7012 formed between a superior surface of the corrugated structure 7002and the top structure 7010. In addition, the layer 7001 comprises aplurality of inferior channels 7022 between an inferior surface of thecorrugated structure 7002 and the base structure 7020. The HME 7000allows for a flow of breathable gas and expiratory gas to flow throughthe plurality of superior 7012 and inferior 7022 channels along asurface of the corrugated structure to exchange heat and moisture.Moisture is absorbed from the expiratory gas exhaled from a patient andretained in the material of the corrugated structure 7002. The materialof the corrugations 7030, the top structure 7010, and/or the basestructure 7020 may comprise paper or a paper based material that is ableto absorb water and/or heat. The material of the corrugations 7030, thetop structure 7010, and/or the base structure 7020 may be porous,water-permeable, and/or air-permeable. The retained moisture maysubsequently be redelivered to the patient by humidifying a flow ofbreathable gas delivered to the patient's airways. In other words, theflow of breathable gas delivered to the patient's airways may absorbmoisture from the HME 7000. FIG. 25B depicts the various dimensions of aHME according to these examples.

The plurality of corrugations 7030 increase the surface area of thecorrugated structure 7002 that allows for an increase in active surfacearea for the exchange of heat and moisture occurring between thecorrugated structure 7002 and the surrounding volume provided by theplurality of superior 7012 and inferior 7022 channels. The top structure7010 and the base structure 7020 may also be formed from the same heatand moisture exchanging material as the corrugated structure 7022.Alternatively, the top structure 7010 and/or the base structure 7020 maybe formed of a rigid or semi-rigid material that does not absorbmoisture to support the corrugated structure 7002.

The humidification performance of the HME 7000 is dependent on theeffective surface area of the HME 7000 provided in a fixed volume ofspace. The effective surface area is the surface area of the HME 7000that is exposed to the flow of breathable gas flowing along the surfaceof the HME where heat and moisture exchange occurs. The surface area perunit volume of the HME 7000 can be adjusted by providing corrugations7030 within the heat and moisture exchange portion of the HME 7000.Furthermore, the surface area per unit volume may also be adjusted bymodifying at least one of the fin thickness, pitch or height of thecorrugations or flutes, which have an impact on the surface area perunit volume of the HME 7000.

The HME 7000 may comprise a plurality of layers 7001 stacked along avertical axis of the HME 7000, as shown in FIG. 25C. The layers 7001 maybe vertically stacked such that the base structure 7020 is stacked ontop of the corrugated structure 7002 of an underlying adjacent layer7001. There may be also several layers 7001 of HME stacked in thehorizontal direction. Having a number of layers 7001 comprisingcorrugated structures 7002 that are stacked along a vertical axis of theHME 7000 further increases the surface area per unit volume of the HME.This increased surface area within a predefined volume allows forincreased efficiency in heat and moisture exchange of the HME 7000.Furthermore, the layers 7001 may be compressed under a preload, asdepicted in FIG. 25D, to increase the number of layers within a fixedvolume to increase the surface area per unit volume. The preload iscalculated by the formula:

$P = {1 - \left( \frac{h_{final}}{h_{start}} \right)}$where P is the Preload and h_(start) is the corrugation or flute heightprior to compression and wherein h_(final) is the height of thecorrugation post-compression.

Alternatively, the final three-dimensional shape of the HME 7000 may beformed by combining layers 7001 of different sizes and shapes to producea HME 7000 of irregular shape adapted to fit within a plenum chamber3200 of the patient interface 3000. The layers 7001 may be laser cut toform the desired shape and size.

As shown in FIG. 25E, displaying an alternative example, the HME 7000may be rolled from a single strip layer 7001 comprising a corrugatedstructure 7002 extending from the surface of the base structure 7020 toform a plurality of corrugations 7030. The single strip layer 7001 maybe rolled such that the upper folded portion 7031 of the corrugations7030 engages the inferior surface of the base structure 7020. Thisconfiguration ensures that the plurality of channels 7012 is maintainedbetween each roll of the single strip layer 7001.

As mentioned above, the CFV may reduce the vent flow rate over the samepressure range as compared to the standard FFM nom flow vent. Thisreduction in flow may reduce the HME vent flow, thereby reducinghumidity losses. In other words, less flow occurs at the same pressuresin the CFV system when compared to the standard vent system,consequently reducing the HME vent flow. This reduction in HME vent flowmay enhance the capability of the HME to capture and redeliver humidityfrom the expired gas flow, thereby synergistically enhancing the HMEeffect to reduce mucosal drying.

The CFV membrane may allow the vent flow to be maintained at or abovethe minimum required level within the therapeutic pressure range and mayalso regulate the vent flow to below that which would occur with astandard static vent. Thus, CO2 washout would always remain atsufficient levels. The vent flow may be tuned such that it allows theminimum level required of CO2 washout. This would result in the ventflow being minimized, which would in turn minimize the loss of moisturefrom the HME.

Another way of reducing the HME vent flow is to redirect the flowdirection such that less flow passes through the vent and is redirectedback into the air delivery circuit. That is, the flow may be redirectedsuch that it minimizes HME vent flow, wherein flow penetrates the HMEand then flows directly out of the vent. The redirection of flow can beachieved by structures, e.g., baffles, positioned in the flow pathbetween the HMX and the vent such that less flow is directed out thevent into the atmosphere.

FIGS. 38A to 38C depict an example of an HME housing 9400 according toan example of the present technology. The HME housing 9400 may have atwo-part construction that includes a patient-side HME housing portion9402 and an atmosphere-side HME housing portion 9404. The patient-sideHME housing portion 9402 and the atmosphere-side HME housing portion9404 may be assembled together to retain HME material therein. Thepatient-side HME housing portion 9402 may include a patient-side HMEhousing portion cross-bar 9406 to retain the HME material in an axialdirection towards the patient in use and the atmosphere-side HME housingportion 9404 may include an atmosphere-side HME housing portioncross-bar 9408 to retain the HME material in an axial direction towardsthe atmosphere in use. The atmosphere-side HME housing portion 9404 mayalso include one or more openings 9410 that connect to correspondingtabs 9412 of the patient-side HME housing portion 9402 to join bothportions together. The connection between the openings 9410 and the tabs9412 may comprise a snap-fit and may be releasable to allow the HMEhousing 9400 to be disassembled so the HME material can be removed forcleaning or replacement.

FIGS. 39A to 39C depict another example of an HME housing 9400 accordingto an example of the present technology. The HME housing 9400 may have atwo-part construction that includes a patient-side HME housing portion9402 and an atmosphere-side HME housing portion 9404. The patient-sideHME housing portion 9402 and the atmosphere-side HME housing portion9404 may be assembled together to retain HME material therein. Thepatient-side HME housing portion 9402 may include a patient-side HMEhousing portion cross-bar 9406 to retain the HME material in an axialdirection towards the patient in use and the atmosphere-side HME housingportion 9404 may include an atmosphere-side HME housing portioncross-bar 9408 to retain the HME material in an axial direction towardsthe atmosphere in use. The atmosphere-side HME housing portion 9404 mayalso include one or more openings 9410 that connect to correspondingtabs 9412 of the patient-side HME housing portion 9402 to join bothportions together. The connection between the openings 9410 and the tabs9412 may comprise a snap-fit and may be releasable to allow the HMEhousing 9400 to be disassembled so the HME material can be removed forcleaning or replacement. The atmosphere-side HME housing portion 9404may also include an atmosphere-side HME housing portion ring 9414 andextending from the atmosphere-side HME housing portion ring 9414 is anHME inner housing 9416 which may contain the HME material. The HME innerhousing 9416 along with the patient-side HME housing portion 9402 andthe atmosphere-side HME housing portion 9404 may form an HME bypasspassage 9418 to allow a portion of the flow traveling through the HMEhousing 9400 to bypass the HME material.

5.4.4 Custom Connection

FIG. 6 a illustrates a side view of a fluid connector 9000 with a firstend 9002 and a second end 9004 mated with one another. A portion of afluid conduit 9006, which may be part of the air circuit 4170, isconnected to the second end 9004. Instead of the fluid conduit 9006, anadaptor or connector to a fluid conduit may be provided. An outlet of anRPT device 4000 may comprise a second end 9004 in some forms of thepresent technology.

The fluid connector 9000 may be configured to removable form a sealedconnection to allow a flow of air to travel therethrough, such as fromthe RPT device 4000 to the patient interface 3000. The fluid connector9000 may comprise a plurality of components, such as a first end 9002and a second end 9004, which may be releasably connected to each otherto make and/or break the sealed connection.

The first end 9002 and the second end 9004 may form a pneumatic paththerebetween via complementary sealing portions, and be retained to eachother by complementary retaining portions that may be separate portionsto the complementary sealing portions. Accordingly, each of the firstend 9002 and the second end 9004 may comprise a separate sealing portionand a retaining portion, as is described in further detail elsewhere inthe present document.

Where the sealing function and the retaining function are performed byseparate complementary portions, each of the sealing and/or theretaining functions may be more readily optimised, to address one ormore of competing design requirements. For example, where one pair ofcomplementary portions function to seal and retain two components,formation of a tight seal may lead to a high frictional force,decreasing ease of connection and/or disconnection of the components.

Furthermore, where the usability of connection/disconnection isimproved, the seal may not be as robust, such as in cases where the twocomponents may be subject to forces and/or torques in varying directionsand magnitudes. In the cases of a fluid connector such as thosedescribed in the present document, a patient wearing a patient interface3000 may move about while asleep, or preparing to go to sleep, causingthe fluid connector to be pulled and/or twisted in various directions.

Thus, one aspect of the present technology relates to a fluid connector9000, wherein the first end 9002 and the second end 9004 are connectedto each other by complementary sealing portions and complementaryretaining portions.

In one form, the first end 9002 and the second end 9004 may comprisecomplementary sealing portions to form an air seal when connected. Theair seal may be configured to form and maintain a sealing engagement toallow a flow of air to travel therethrough. The sealing engagement maybe sufficient to allow a pressurised flow of air to travel therethrough,such as at pressures between 4 cm H₂O to 40 cm H₂O to providerespiratory therapies.

In some forms, the first end 9002 and the second end 9004 may comprisecomplementary portions to retain the first end 9002 and the second end9004. The retaining portions may maintain the first end 9002 and thesecond end 9004 in sealing engagement with each other, such as bypreventing accidental disengagement. The retaining portions may compriselatching mechanisms as will be detailed further in the present document.

FIG. 6 b illustrates a sectional view of the fluid connector 9000 wherethe first end 9002 and the second end 9004 are not connected to oneanother. In this view, a seal portion 9008 is visible. The seal portion9008 may be formed from any material that is suitable for forming a sealin an air path of a device that provides breathing gas to a patient, forexample, silicone. The seal portion 9008 extends around a first opening9010, which is illustrated as the interior of a first tube 9022. Alatching portion 9012, which may be in in the form of a recess, isprovided in the first end 9002. The latching portion 9012 may beprovided on opposed sides as illustrated in FIG. 6 b , on a single sideor all around a periphery of the first end 9002. As illustrated, thelatching portion 9012 is an undercut that is substantially perpendicularto a central axis of the first end 9002. Other angles are possibledepending on the retention force desired.

The second end 9004 includes a sealing surface 9016. The sealing surface9016 may be formed circumferentially around a second opening 9018 thatis illustrated as the interior of a second tube 9020. The sealingsurface 9016 is illustrated as a substantially annular surface thatextends radially and perpendicularly (i.e., at 90°) away from the secondtube 9020. This may result in the sealing surface 9016 beingsubstantially perpendicular to a direction of the fluid flow from thefirst end 9002 to the second end 9004. However, the sealing surface 9016could also extend outward at an angle such that the sealing surface 9016is beveled. For example, the sealing surface could be at 85°, 80°, 75°,70°, 65°, 60°, 55°, 50° or 45° angle, positive or negative, or any valuein between. As can be seen in FIG. 6 b , the second tube 9020 maycomprise an overhang portion 9034 that extends beyond the sealingsurface 9016 towards the seal portion 9008. This may result in theoverhang portion 9034 of the second tube 9020 extending through the sealportion 9008 as illustrated in FIG. 6 c . It will be understood that thesecond tube 9020 need not comprise an overhang portion in some examplesof the present technology.

The overhang portion may be configured to align the first end 9002 withthe second end 9004 in one or more directions. The overhang portion 9034may be configured to be inserted into a guide portion 9038 on the firstend 9002 to act as a lead-in and align the second end 9004 with thefirst end 9002 in a radial (or transverse) direction. Thus the first end9002 and second end 9004 may have a male/female relationship.Additionally, a stop 9030 may be provided to limit travel of the secondtube 9020, for example by abutting the overhang portion 9034 at thelimit of travel. Although the overhang portion 9034 is shown as a tube,the overhang portion may not extend continuously around a circumferenceof the second end 9004, as it would be internal to the seal created bythe complementary sealing portions (seal portion 9008 and sealingsurface 9016). The overhang portion may extend only partially throughthe seal portion 9008, such as in castellated extensions, tabs, ribs andthe like.

With the configuration illustrated in FIG. 6 c , the interior flow pathof the fluid connector 9000 defined by the first tube 9022, second tube9020 and stop 9030 may have very little flow restriction because theinterior flow path is substantially the same as the interior of thefluid conduit 9006, for example as evaluated in cross section shape andsize. Thus the fluid connector 9000 may have negligible pressure dropwhen air is flowing through the fluid connector 9000 throughout apatient's breathing cycle and therapy pressure (e.g., at pressuresbetween 4 cm H₂O to 40 cm H₂O).

The seal portion 9008 may include a portion that contacts the sealingsurface 9016 in any form that is suitable for forming a face seal, suchas by tangential contact therebetween. As illustrated, the seal portion9008 contacts the sealing surface 9016 with a substantiallyfrustoconical shape, which is similar to a bellows-shape or partialbellows-shape. Alternatively, a partial spherical, or partial toroidalsurface may be provided on the seal portion 9008. With any of theseshapes, the seal portion 9008 may contact the sealing surface 9016before the latching portion 9012 and complementary latching portion 9014are fully or even partially engaged. Alternatively, the seal portion9008 and sealing surface 9016 may be separated by a gap even after thelatching portion 9012 and complementary latching portion 9014 are fullyengaged. In this scenario, internal pressurization may cause the sealportion 9008 to move into contact with the sealing surface 9016 and forma seal.

The seal portion 9008 may comprise a resilient and compliant materialsuch that it may deform under load, while maintaining its originalconfiguration when the load is removed therefrom. The seal portion 9008may be configured to be readily deformed under load to form and/ormaintain a seal with the sealing surface 9016. In some forms, the sealportion 9008 may comprise a membrane composed of silicone. The siliconemembrane seal portion 9008 may be sufficiently compliant that it woulddeform to move into contact with the sealing surface 9016 due to thepressure caused by the air flow. The silicone membrane seal portion 9008may additionally or alternatively be sufficiently compliant such that itwould maintain a sealing engagement with the sealing surface 9016 evenwhen compressed from its undeformed configuration.

The proposed configurations of the seal portion 9008 may provide a sealthat is compliant with respect to a mating direction between the firstend 9002 and the second end 9004 (e.g., leftwards in FIG. 6 b ) and/orcompliant in a direction radial to an axis defined by a direction ofengagement between the first end 9002 and the second end 9004 (e.g., upand down in FIG. 6 b ).

The force necessary to compress the seal portion 9008 (e.g. whencompression is required to form and/or maintain a seal) may besufficiently low so as to not be a significant compressive force. Forexample, the force required to compress the seal portion 9008 may beless than a force required to engage the latching portion 9012 with thecomplementary latching portion 9014, such as to overcome any friction inconnecting the second end 9004 and the first end 9002. Alternatively,the force required to compress the seal portion 9008 may be less thanhalf of the force required to engage the latching portion 9012 with thecomplementary latching portion 9014. Alternatively, the force requiredto compress the seal portion 9008 may be less than one tenth of theforce required to engage the latching portion 9012 with thecomplementary latching portion 9014. Thus in a configuration where theseal portion 9008 contacts the sealing surface 9016 before the latchingportion 9012 and complementary latching portion 9014 are fully engaged,a user may not encounter significant force that would be mistaken forfull engagement. In some forms, any force caused by a compression of theseal portion 9008 for connection of the second end 9004 and the firstend 9002 may be sufficiently small that it is substantiallyimperceptible to a user. That is, the force perceived by a user in aconfiguration wherein the seal portion 9008 is removed from the firstend 9002 may be substantially identical to a configuration where theseal portion 9008 must be compressed for connection.

The shapes of the seal portion 9008 according to the present technologymay provide a seal that is compliant opposite to a mating directionbetween the first end 9002 and the second end 9004 (e.g., rightwards inFIG. 6 b ). This may allow for a seal portion 9008 that can seal withthe sealing surface 9016 even if a gap exists between seal portion 9008and sealing surface 9016 when the fluid connector 9000 is unpressurized.When pressure is provided to an interior of the fluid connector 9000(e.g., to the first tube 9022), the seal portion 9008 may expand towardsand contact the sealing surface 9016 to form a seal. With thisconfiguration, a user should not encounter any additional force whenconnecting the first end 9002 to the second end 9004 beyond the forcenecessary to engage the latching portion 9012 and complementary latchingportion 9014.

Although specific configurations of the seal portion 9008 are discussedabove, other configurations are possible. For example, some forms of theseal portion 9008 may include an o-ring or a gasket material.

Either the seal portion 9008 or the sealing surface 9016 or both may beconfigured such that misalignment between the seal portion 9008 andsealing surface 9016 still results in a seal between the seal portion9008 and the sealing surface 9016. For example, the seal portion 9008and/or the sealing surface 9016 may be configured to form a sealtherebetween while allowing for a range of misalignments in radial (ortransverse) and/or axial directions.

For example, the sealing surface 9016 may comprise an annular shape (asshown in FIG. 6H) configured to form a face seal with a surface of theseal portion 9008 in a plurality of radial positions. That is, the sealportion 9008 and the sealing surface 9016 may form a seal therebetweenalthough an axis of the first tube 9022 and an axis of the second tube9020 may be misaligned, for example by 0.5 mm, 1 mm, 1.5 mm, 2 mm, 3 mmor 4 mm. In one form, the sealing surface 9016 may comprise asufficiently wide annular portion such that the seal portion 9008 may beable to form a seal thereto.

The second end 9004 also includes a complementary latching portion 9014.The complementary latching portion 9014 is illustrated as a cantileveredhook including a protrusion that mates or engages with the latchingportion 9012. As with the latching portion 9012, the complementarylatching portion 9014 may be provided on a plurality of (e.g. opposed)sides as illustrated in FIG. 6 b or on a single side. The complementarylatching portion 9014 may be in the form of U-shaped or C-shapedcut-through as illustrated in FIG. 6 d . The complementary latchingportion 9014 may be depressed to engage or disengage the complementarylatching portion 9014 from the latching portion 9012 and allowengagement or disengagement between the first end 9002 and the secondend 9004. Although providing more than two of the complementary latchingportion 9014 is possible, doing so may make it unnecessarily difficultto disengage the second end 9004 from the first end 9002.

In combination, the stop 9030 and latching portion 9012 may define apredetermined distance (travel) that the second end 9004 can move withrespect to the first end 9002 while the two ends are connected. Forexample, if a first axial distance between the stop 9030 and latchingportion 9012 is greater than a second axial distance between an end ofthe second tube 9020 and the protrusion on the complementary latchingportion 9014, then the difference between the first axial distance andthe second axial distance will define a predetermined amount of travelthat is non-zero. If the first axial distance and the second axialdistance are equal, then no travel will be possible. However, there maybe benefits associated with a non-zero travel at least with respect toease of manufacture because a non-zero travel will allow formanufacturing tolerance that may reduce cost. Thus it may also bebeneficial for the seal portion 9008 to be configured to form a sealwith the sealing surface 9016 with a worst case manufacturing toleranceand after a predetermined amount of wear and/or creep in the fluidconnector 9000. The shapes for the seal portion 9008 discussed above mayallow for the seal portion 9008 to account for such a worst casescenario.

As best seen in FIG. 6 b , the second end 9004 may include an innerportion 9024 and an outer portion 9026 that are rotatably coupled to oneanother at an interface 9028. The inner portion 9024 may include theseal portion 9008 and the outer portion 9026 may include thecomplementary latching portion 9014. As illustrated, the inner portion9024 is rigidly or fixedly connected to the fluid conduit 9006 such thatthe inner portion 9024 and the fluid conduit 9006 may rotate togetherwith respect to the outer portion 9026. At least a part of the fluidconduit 9006 may be overmolded onto the inner portion 9024 to form therigid connection therebetween. In other forms, the fluid conduit 9006may be friction fit, or interference fit into the inner portion 9024 soas to form a rigid connection.

As best viewed in FIG. 6 d , the outer portion 9026 may have an outerprofile that has four sides but also have some features of a circle,which may be uniquely identifiable in comparison to a typical circularprofile. The first end 9002 may include a complementarily shaped recess.Thus the first end 9002 includes a female portion and the second end9004 includes a male portion. Including male and female portions in theabove form, or any other non-standard shape or configuration, mayprovide benefits. First, the fluid connector 9000 comprisingnon-standard shapes and/or configurations may not conform to industrystandards (e.g., ISO 5356-1), which include use of a circular spigotincluding a lead-in taper, onto which a cuff (e.g. rubber) is insertedover. Although not confirming to an industry standard may seem counterintuitive, there may be benefits. For example, the fluid connector 9000may be used to connect an RPT device and patient interface that aredesigned to operate optimally together. For example, if the RPT deviceprovides a lower flow rate that can only be taken advantage of by apatient interface that is designed to operate with that lower flow rate,having a fluid connector 9000 that does not mate with an industrystandard will ensure that only the correct RPT device and patientinterface are used together. Second, particularly with the illustratedprofile, the first end and the second end 9004 may be mated with oneanother only in a predetermined number of relative orientations (e.g.,four). The present four-sided shape also may provide well-defined sidesthat are easy to identify and grip for actuation of the complementarylatching portion 9014. Thirdly, a non-standard shape such as thatdescribed herein, or others, may allow a user to readily identify whichend of a patient conduit 4170 may be a complementary connector toanother connector, such as an outlet of the RPT device.

FIG. 6 e illustrates another example of a present technology, wherein aport 9032 is included in the first end 9002. The port 9032 may be usedto sense pressure downstream of a blower and outside of a housing of theblower, such as by sensing a pressure downstream of the RPT device. Theport 9032 may be in fluid connection to the second end 9004 to determinea pressure of the air in the second opening 9018.

In one form, the port 9032 may be in fluid communication with aninterior of the second opening 9018, such as by forming a fluidconnection to an opening in the interior of the seal portion 9008. Theopening in the interior of the seal portion 9008 may be in turn in fluidcommunication with a pressure tap 9036 to the second opening 9018. Thusthe first end 9002 and the second end 9004 may form two fluidconnections therebetween when connected to each other. The port 9032 mayprovide an advantage of being able to measure pressure closer to apatient than if pressure is measured in the RPT device. Due to pressurelosses inherent in internal fluid flow as well as possible leaksthroughout the air path from the blower to the patient, measuring thepressure closer to the patient may provide a more accurate measurementthan a pressure measure carried out further from the patient.

Also, the present arrangement allows for the second end 9004 to berotated with respect to the first end 9002 while still maintaining twofluid connections (i.e. one to deliver the flow of air, another tomeasure pressure). This may be advantageous for allowing the fluidconduit 9006 to rotate with respect to the outer portion 9026, thusreducing torque imposed on the fluid conduit and/or the outer portion9026. Furthermore, such a configuration may also allow a user to connectthe first end 9002 and the second end 9004 in one of a plurality ofrotational orientations to each other while maintaining the two fluidconnections.

FIG. 6 f illustrates the first end 9002 integrated into an RPT devicewith the second end 9004 disconnected. FIG. 6 g illustrates the firstend 9002 integrated into the RPT device with the second end 9004connected.

Although the preceding description generally describes both halves of aconnector system together, e.g., a first end 9002 and a second end 9004,it is to be understood that the description of either half may beconsidered in isolation.

It may also be advantageous to ensure that the appropriate masks areused with the CFV membrane regulated vents. Masks according to examplesof the present technology may be non-vented masks designed specificallyto be compatible with the CFV membrane regulated venting describedabove. The system may be designed such that the flow generator is alsocompatible with the vent adaptor, meaning that the flow generator willbe programmed to work with a mask system having a constant vent flow.That is, each mask type (nasal, pillows and full face), may connect tothe same vent adaptor and, therefore, the vent adaptor should allow forenough CO2 washout for each of the mask types. The lowest CO2 washout isgenerally seen in the full face mask as there is an increase in thevolume of mask dead space. Hence, the vent adaptor must allow forsufficient CO2 washout for the full face mask (i.e., the worst casescenario). Since the system of the present technology, including theflow generator, vent adaptor, and each mask type, may be designedspecifically to work together, it may be advantageous to preventnon-compatible masks from connecting to the CFV connector.

As such, a connection mechanism may be provided such that the sealformed between two detachably connecting components is achieved by theconnection mechanism. As previously described, the nasal and pillowsmask may connect to a short tube connector, which will then connect tothe vent adaptor. In contrast, the full face mask may connect directlyto the vent adaptor 9100. In another example, the HME may comprise aseparate detachable housing, which could be detached from the ventadaptor. However, to reduce overall size, the HME may be incorporatedinto the vent adaptor with the CFV unit, wherein the HME slides into thesame housing as the CFV. Such a design means that when the HME isremoved there may be an unused, empty space in the CFV housing of thevent adaptor 9100.

In the full face version of a mask according to the present technologythe short tube connector end may be formed as the inlet of the full facemask. That is, the same bellows engaging surface is designed as part ofthe mask shell, which may form part of the mask plenum chamber.

The bellows sealing membrane may be structured to move under pressuresuch that the membrane moves towards the sealing surface on the opposingconnector. The pressure supported seal may mean that the seal betweenthe CFV unit and the connector remains robust under high pressures.

The bellows seal may allow for a seal to be formed between the CFV unitand the connector with minimal friction between the two components,which allows a swivel connection. For example, sealing usinginterference fit, a lip seal, a gasket configuration, or other forms ofcompression seals between the components may not allow for easy enoughmovement between the components such that the components can swivel,while maintaining a robust seal.

5.4.5 Exemplary Vent Adaptors

An example of a vent adaptor 9100 and its components are shown in FIGS.7A-14D. The vent adaptor 9100 according to this example of the presenttechnology may include a conduit connector 9110, a vent housing 9120, avent diffuser cover 9130, a membrane 9140, a CFV ring 9150, a venthousing connector 9160, a heat and moisture exchanger (HME) clip 9170, aHME housing 9180, a bellows seal 9190, and a vent adaptor connector9200.

The vent housing 9120 may include an end 9121 with protrusions 9122 toconnect the vent housing 9120 to the conduit connector 9110 at a ventadaptor end 9112. The end 9121 may define the central orifice of thevent housing 9120 through which the flow of pressurized gas is providedto the patient. The vent housing 9120 may include external vent holes9125 and internal vent holes 9126 that define passageways for ventingpressurized gas from the RPT system, i.e., gas may be discharged fromthe internal vent holes 9126, through said passageways, to the externalvent holes 9125, and out to atmosphere. The vent housing 9120 may alsoinclude a tab 9123 joined to a lip 9124 via a support 9128 to releasablyattach the vent housing 9120 to the vent housing connector 9160 and thevent adaptor connector 9200. The patient may actuate the tab 9123 todepress the support 9128 such that the lip 9124 is disengaged from thevent housing connector 9160 and the vent adaptor connector 9200. Whenattached, the lip 9124 allows the vent housing 9120 to rotate relativeto the vent adaptor connector 9200 while remaining connected. The venthousing 9120 may also a shoulder 9127 to fit into a corresponding notch9164 of the vent housing connector 9160. The vent housing 9120 may alsoinclude notches 9129 to receive corresponding bellows seal connectors9191 that attach the bellows seal 9190 to the vent housing 9120 to sealthe interior of the vent adaptor 9100 against the vent adaptor connector9200 when assembled.

The vent housing connector 9160 may include a first bar 9161 and asecond bar 9162 that form a receptacle 9163 that receives acorresponding lip 9124 of the vent housing 9120 to attach the venthousing connector 9160 to the vent housing 9120. The notch 9164 alsoreceives the shoulder 9127 of the vent housing 9120, as described above.The vent housing connector 9160 may also include a curved outer surface9165.

The bellows seal 9190 may be a bellows seal similar to the featuresdescribed above in relation to FIGS. 6A-6H. The bellows seal 9190 mayhave a shoulder surface 9194 with bellows seal connectors 9191 to attachthe bellows seal 9190 to the notches 9129 of the vent housing 9120. Thebellows seal 9190 may also have an inner surface 9193 that is contactedby the pressurized gas and urged outward such that an outer surface 9192forms a seal against the vent adaptor connector 9200 when assembled.

The vent adaptor connector 9200 may have an orifice 9201 through whichpressurized gas passes from the vent adaptor 9100 and on to the patientduring therapy. Also, the exhaled gas may be discharged into the ventadaptor 9100 via the orifice 9201. The vent adaptor connector 9200 maybe connected at the orifice 9201 to the patient interface via anothertube (not shown). The vent adaptor connector 9200 may also have a rim9202 to connect to the lip(s) 9124 of the vent housing 9120 to allow thevent housing 9120 to connect to and rotate relative to the vent adaptorconnector 9200. It should be understood that in another form of thepresent technology, the vent adaptor connector 9200 may be connecteddirectly to the patient interface or it may be formed integrally withthe patient interface, e.g., the mask shell.

The vent adaptor 9100 may also include an HME clip 9170 and an HMEhousing 9180 to retain HME material within the vent adaptor 9100 in aposition that is between the internal vent holes 9126 and the patient,as described above. The HME material (not shown) may be a coiled orcylindrical structure that is inserted into the HME housing 9180 andretained therein by the HME clip 9170. The HME clip 9170 may have a pairof arms 9171 extending from a central shaft 9172. The central shaft 9172may extend through the center of the HME material to secure a shaft end9173 into a receiver 9183 suspended on a cross-member 9182 of the HMEhousing 9180 to secure the HME material inside of the HME housing 9180.The HME housing 9180 may also include a pair of slots 9181 in an outerwall 9184 that correspond to the arms 9171 and receive arm ends 9174such that when assembled the HME clip 9170 does not rotate relative tothe HME housing 9180. Thus, the HME material would be secured betweenthe arms 9171 and the cross-member 9182. The outer wall 9184 may includea plurality of cut-outs 9185.

The conduit connector 9110 may include the vent adaptor end 9112 and aconduit end 9111. As explained above, the vent adaptor end 9112 mayconnect to the vent housing 9120 and the conduit end may be connected toa conduit (not shown) that is connected at the other end to an RPTdevice to receive a flow of pressurized gas. The conduit connector 9110may also include anti-asphyxia valve (AAV) openings 9113.

Another example of a vent adaptor 9100 and its components are shown inFIGS. 15A-15F. This example includes may features similar to theexamples shown in FIGS. 7A-14D above. In this example, the vent adaptorconnector 9200 includes a rim 9203 that connects to the tab 9123 of thevent housing 9120 to connect the vent adaptor connector 9200 to the venthousing 9120. Also, this example shows an anti-asphyxia valve (AAV) 9135that may installed in the conduit connector 9110. The conduit connector9110 may also have a ring 9115 to connect to a conduit (not shown).Also, in this example the bellows seal 9190 can be seen attached to thevent housing connector 9160. The vent housing connector 9160 also has aridge to allow for attachment to the vent housing 9120 by the tab 9123.Furthermore, examples of HME material 9145 and the diffuser 9146 areshown.

Another example of a vent adaptor 9100 and its components are shown inFIGS. 21A-21F. This example includes may features similar to theexamples shown in FIGS. 7A-14D and FIGS. 15A-15F above. In this example,the HME housing 9180 is not completely contained inside of the ventadaptor 9100. Rather, it is exposed partially such that it forms part ofthe structure that connects the vent housing 9120 to the vent adaptorconnector 9200.

Another example of a vent adaptor 9100 and its components are shown inFIG. 22 . This example includes may features similar to the examplesshown in FIGS. 7A-14D and FIGS. 15A-15F above. FIG. 22 also includes aflap retaining structure 9141 that may be attached to the HME clip 9170on one side and abut the flap 9140 on the other side to hold the flap9140 in an operational position relative to the vent housing 9120.

Another example of a vent adaptor 9100 and its components are shown inFIGS. 24A-24B. This example includes may features similar to theexamples shown in FIGS. 7A-14D and FIGS. 15A-15F above.

FIG. 23 depicts a diagram of the ways the vent adaptor 9100 may beattached to different patient interfaces. In the case of the nasalcushion patient interface 3000A or the nasal pillows patient interface3000B, the vent adaptor 9100 may be joined to either patient interfacevia a short tube 9210. One end of the short tube 9210 may be joined tothe patient interface 3000A, 3000B and the other end may be joined tothe vent adaptor connector 9200 described above. Alternatively, in thecase of the full face patient interface 3000C, the vent adaptor 9100does not include the vent adaptor connector 9200 and the vent adaptor9100 is connected directly to the full face patient interface 3000C suchthat no short tube 9210 is provided.

FIGS. 33A to 33G depict another example of a vent adaptor 9100 accordingto an example of the present technology. This vent adaptor 9100 may beconnected to a patient interface 3000, as shown in FIG. 35 for example,to provide the functions of its components.

The vent adaptor includes an elbow assembly 9220 to provide a fluidconnection with the patient interface 3000, e.g., via a connection port3600 on the plenum chamber 3200. This example of the elbow assembly 9220includes an elbow frame 9222 and an elbow overmould 9224. The elbowassembly 9220 may provide a releasable connection with the plenumchamber 3200 at the connection port. The elbow frame 9222 may includetabs that are elastically deformable for the releasable connection andthe elbow overmould 9224 may provide a fluid-tight seal around openingsin the elbow frame 9222, as well as added resiliency for the elbow frame9222. The elbow assembly 9220 may also be rotatable relative to theplenum chamber 3200 to reduce the effects of tube drag from the othercomponents of the vent adaptor 9100 and the air circuit 4170. The elbowassembly 9220 may also be removably connected to a patient interface3000 and may be able to swivel relative to the patient interface 3000.

The vent adaptor 9100 may also include a short tube assembly 9210. Theshort tube assembly 9210 may decouple the other components of the ventadaptor 9110, e.g., the vent housing 9320 and the vent core structure9300, from the elbow assembly's 9220 connection with the plenum chamber3200. By decoupling the other components of the vent adaptor 9110 inthis manner, the mass that must be carried directly on the patient'shead via the patient interface 3000 can be reduced, which in turnprovides a lighter and more comfortable experience for the patient. Theshort tube assembly 9210 may include a tube 9212, which may be comprisedof one or more helical coils. The short tube assembly 9210 may include atube-elbow connector 9216 to provide a connection with the elbowassembly 9220. The connection between the tube-elbow connector 9216 andthe elbow assembly 9220 may comprise a snap-fit. The connection betweenthe tube-elbow connector 9216 and the elbow assembly 9220 may bepermanent—in other words, the connection may not be separated withoutdamaging the components. The short tube assembly 9210 may include atube-housing connector 9214 to provide a connection with the venthousing connector 9160. The connection between the tube-housingconnector 9214 and the vent housing connector 9160 may comprise asnap-fit. The connection between the tube-housing connector 9214 and thevent housing connector 9160 may be permanent—in other words, theconnection may not be separated without damaging the components.

The vent adaptor 9100 may include a vent housing connector 9160 to jointhe short tube assembly 9210 with the vent housing 9320. As describedabove, the vent housing connector 9160 may be joined to the short tubeassembly 9210 with the tube-housing connector 9214 that may be asnap-fit and that may be permanent. The vent housing connector 9160 mayalso include a bayonet connector 9166 to facilitate a releasablebayonet-style connection with the vent housing 9320 or a heat andmoisture exchanger (HME) housing 9400 such as those shown in FIGS. 38Ato 39C. Thus the HME associated with the HME housing 9400 may beoptional and, as such, is not shown in FIGS. 33A to 33G. The bayonetconnectors 9166 may be male or female. Also, making the vent housing9320 removably connectable to the vent housing connector 9160 allows thevent components to be removed and disassembled for cleaning.

FIGS. 34A to 34G show examples of the vent housing 9320, the flap ormembrane 9140, the vent core structure 9300, the diffusing member 9146,the diffuser retaining ring 9148, and the vent diffuser cover 9330.These components may be assembled into a sub-assembly, as shown in FIGS.34A to 34G, and joined to the vent housing connector 9160 for use. Thecomponents of the sub-assembly depicted in FIGS. 34A to 34G may beinseparable via a permanent snap-fit or the components may be separableby the user. In the case of inseparability, the snap-fit may bepermanent such that the components cannot be separated without damagingthem.

The vent housing 9320 may also include bayonet connectors 9322 tocorrespondingly connect with the bayonet connectors 9166 of the venthousing connector 9160 to removably connect the vent housing 9320 to thevent housing connector 9160. The vent housing 9320 may also include amembrane retainer 9324 to hold the membrane 9140 against the vent corestructure 9300 when assembled. The membrane retainer 9324 may comprisean open, radial, and cage-like structure to allow the vent flow totravel through the membrane retainer 9324 for discharge by the vent corestructure 9300. The membrane retainer 9324 may also be open in itscenter to allow the therapy flow to pass along to the patient from theRPT device 4000.

The flap or membrane 9140 may be positioned between the membraneretainer 9324 and the vent core structure 9300. The membrane 9140 may beheld in position between these two structures, but may be otherwise befree to be deformed by pressure within the vent adaptor 9100. Themembrane 9140 may function similarly to other examples of the membrane9140 disclosed above.

The vent core structure 9300 may include an inlet 9301 to allow the flowof gas generated by the RPT device 4000 to pass through the vent adaptor9100 and along to the patient for therapy. The vent core structure 9306may include a vent core extension 9306 through which the inlet 9301 maybe defined. The vent core extension 9306 may extend axially and mayinclude air circuit connectors 9302 to connect the vent core 9300 to theair circuit 4170. As can be seen, the vent core extension 9306 is shapedand dimensioned to extend through the diffuser retaining ring 9148, thediffuser 9146, and the vent diffuser cover 9330 to align thesecomponents when the vent adaptor 9100 is assembled. The vent corestructure 9300 may also include clips 9304 on an alignment structure9312 that connect to the connection surface 9334 of the vent diffusercover 9330. The clips 9304 may be connected to the connection surface9334 with a snap-fit to allow the vent diffuser cover 9330 to be removedfor disassembly to allow cleaning and/or replacement of vent adaptorcomponents 9100 such as the diffuser 9146. The alignment structure 9312may also facilitate axial alignment of the vent core structure 9300 withthe diffuser 9146 and the vent diffuser cover 9330 by virtue ofcorresponding shapes.

The vent core structure 9300 may also include a plurality of outerorifices 9308 and a plurality of inner orifices 9310. The plurality ofinner orifices 9310 may be configured such that vent flow to atmospherethrough the inner orifices 9310 may be obstructed or restricted by themembrane 9140 in use. The plurality of outer orifices 9308 may beconfigured such that vent flow to atmosphere through the outer orifices9308 may not be obstructed or restricted at any point by the membrane9140 in use. However, the membrane 9140 may also be configured such thatit does not completely occlude the inner orifices 9310 at any pressureat least within a typical range of therapeutic pressure (e.g., betweenabout 6 cmH2O and about 20 cmH2O). In other words, vent flow may bedischarged through both the inner orifices 9310 and the outer orifices9308 at any pressure within a typical range of therapeutic pressure,while the pressure within the vent adaptor 9110 deforms the membrane9140 to vary the proportion of vent flow traveling through the outerorifices 9308 and the inner orifices 9310 so as to maintain a constantvent flow rate, as described above.

The diffuser 9146 may include a diffuser opening 9147 through which thevent core extension 9306 may pass. The diffuser 9146 may include similarfeatures to the diffusers described above.

The diffuser 9146 may be held in position downstream of the innerorifices 9310 and the outer orifices 9308 relative to the vent flow bythe diffuser retaining ring 9148 and the vent diffuser cover 9330. Thediffuser retaining ring 9148 may be secured to the vent diffuser cover9330, e.g., with a snap-fit, to retain the diffuser 9146. The diffuserretaining ring 9148 may include radial diffuser retainers 9149 to holdthe diffuser 9146 against the vent diffuser cover 9330. The diffuserretaining ring 9148 and the radial diffuser retainers 9149 may defineposterior vent outlets 9342 around the vent housing 9320. Vent flowexiting the vent core structure 9300 may pass through the diffuser 9148and out through the posterior vent outlets 9340. The vent diffuser cover9332 may include a series of cover spacers 9332 spaced radially aboutthe vent diffuser cover 9330 to define the anterior vent outlets 9342.Vent flow exiting the vent core structure 9300 may pass through thediffuser 9148 and out through the anterior vent outlets 9342.

The exemplary vent adaptor 9100 disclosed above and in FIGS. 33A to 34Gis shown connected to a patient interface 3000 in FIG. 35 . The elbowassembly 9220 is excluded in this example, because the plenum chamber3200 includes a connection port 3600 that is angled so as to point in aninferior direction relative to the patient's head in use, therebydirecting the vent adaptor 9100 away from the patient's head. Also, theshort tube assembly 9210 may be permanently connected to the plenumchamber 3200 at the connection port 3600.

FIGS. 37A to 37E depict another example of a vent adaptor 9100 accordingto the present technology. The vent adaptor 9100 may include a plenumchamber connector 9700 to connect the vent adaptor 9100 directly to theconnection port 3600 of the plenum chamber 3200 and/or to a shroud 3305thereof (see FIG. 41 ) to provide a fluid connection for the flow ofpressurized gas from the vent adaptor 9100 to the plenum chamber 3200.

The vent adaptor 9100 may also include a baffle 9600. The baffle 9600may separate the incoming flow of pressurized gas from the RPT device4000 from the outgoing vent flow exiting via the outer orifices 9308 andthe inner orifices 9310 of the vent housing 9120. The baffle 9600 may bepositioned internally of the plenum chamber connector 9700. The baffle9600 and the plenum chamber connector 9700 may be aligned when connectedto form concentric circles.

The vent adaptor 9100 may also include a lip seal 9500 that fits aroundthe exterior periphery of the plenum chamber connector 9700. The lipseal 9500 may form a seal with the interior periphery of the connectionport 3600 of the plenum chamber 3200 and/or the shroud 3305 thereof toprovide a pneumatic seal while allow rotation of the vent adaptor 9100relative to the patient interface 3000.

The vent adaptor 9140 may also include the flap or membrane 9140 toregulate the vent flow through the inner orifices 9310 and the outerorifices 9308 of the vent housing 9120 in accordance with the examplesdescribed above, e.g., the examples pictured in FIGS. 33A to 34G.

The vent housing 9120 may include inner orifices 9310 and outer orifices9308 and these orifices may permit vent flow to exit the vent adaptor9100 to atmosphere, as described in the examples above such as theexamples of FIGS. 33A to 34G.

The vent housing 9120 may also include tabs 9123 and lips 9124 toprovide a releasable and rotatable connection with the connection port3600 of the plenum chamber 3200 and/or the shroud 3305 thereof. The tabs9123 may be manually depressed to release the lips 9123 from acorresponding annular protrusion (not shown) of the connection port 3600of the plenum chamber 3200 and/or the shroud 3305 thereof. Whenconnected, the lips 9124 allow the vent adaptor 9100 to maintain aconnection with the connection port 3600 of the plenum chamber 3200and/or the shroud 3305 thereof while being rotatable to reduce theeffects of tube drag.

The vent housing 9120 may be connected to a conduit connector 9110 thatin turn may connect the vent adaptor 9100 to an air circuit. The conduitconnector 9110 may be in the form of an elbow. The conduit connector9110 may have a conduit end 9111 that connects to the air circuit 4170and a vent adaptor end 9112 that connects to the vent housing 9120. Theconnection between the vent adaptor end 9112 of the conduit connector9110 and the vent housing 9120 may comprise a snap-fit, may be permanentsuch that the connection cannot be separated without damaging at leastone of the components, and/or may be non-rotatable to prevent theconduit connector 9110 from contacting the tabs 9123. The conduitconnector 9110 may also include one or more anti-asphyxia valve (AAV)openings 9113 for the AAV 9135.

The vent adaptor 9100 may also include an air circuit connector 9116that may be attached to the conduit end 9111 of the conduit connector9110. The air circuit connector 9116 may include bayonet connectors 9117to correspondingly connect to the connectors 4175 of the exemplary aircircuit 4170 of FIGS. 36A to 36C. The connection between the air circuitconnector 9116 and the air circuit 4170 may be releasable.

The vent adaptor depicted in FIGS. 37A to 37E may not include heat andmoisture exchanger (HME) material 9145. The absence of a heat andmoisture exchanger material 9145 positioned within the vent flow pathmay minimise vent flow impedance, thereby minimising CO2 build up withinthe plenum chamber 3200. The depicted vent adaptor 9100 may be, forexample, suitable for use with a full face patient interface as depictedin FIG. 41 .

The vent adaptor 9100 depicted in FIGS. 37A to 37E may form an elbowassembly that may be removably connected to a patient interface 3000,e.g., as shown in FIG. 41 , and may be able to swivel relative to thepatient interface.

FIGS. 40 and 41 show further examples of vent adaptors 9100 joined topatient interfaces 3000.

FIG. 40 depicts a patient interface 3000 with a seal-forming structure3100 that forms a seal around only the patient's nose in use (i.e., anasal mask). The vent adaptor 9100 is shown joined to a shroud 3305 thatcovers a portion of the plenum chamber 3200. In this example, the ventadaptor 9100 features are combined in an elbow that is attached directlyand rotatably to the shroud 3305 to provide a fluid connection with theplenum chamber 3200. However, it should be understood that the ventadaptor of FIGS. 33A to 33G could be attached to the shroud 3305 to forma fluid connection with the plenum chamber 3200 via the elbow assembly9220. The shroud 3305 has rigidiser arms 3301 joined to the shroud 3305at hinges 3307. The lateral arms 3301 may include superior attachmentpoints 3302 and inferior attachment points 3304 to attach straps of apositioning and stabilising structure 3300. The superior attachmentpoints 3302 may form loops through which superior straps can be passedand the inferior attachment points 3304 may receive clips 3306, which inturn receive inferior straps.

FIG. 40 depicts an exemplary patient interface 3000 that may include aseal-forming structure 3100 to form a seal over the patient's nose andmouth in use. The vent adaptor 9100, such as the example depicted inFIGS. 37A to 37E, may be connected to the shroud 3305 to provide a fluidconnection with the plenum chamber 3200. The shroud 3305 may be joinedto rigidiser arms 3301 that may have superior attachment points 3302 toattach straps of a positioning and stabilising structure 3300. Theshroud 3305 may be connected to inferior strap connectors 3303 separatefrom the rigidiser arms 3301 to attach straps of a positioning andstabilising structure 3300 at inferior attachment points 3304. Thesuperior attachment points 3302 may form loops through which superiorstraps can be passed and the inferior attachment points 3304 may receiveclips 3306, which in turn receive inferior straps.

5.5 RPT Device

An RPT device 4000 in accordance with one aspect of the presenttechnology comprises mechanical and pneumatic components 4100,electrical components 4200 and is configured to execute one or morealgorithms 4300. The RPT device may have an external housing 4010,formed in two parts, an upper portion 4012 and a lower portion 4014.Furthermore, the external housing 4010 may include one or more panel(s)4015. The RPT device 4000 comprises a chassis 4016 that supports one ormore internal components of the RPT device 4000. The RPT device 4000 mayinclude a handle 4018.

The pneumatic path of the RPT device 4000 may comprise one or more airpath items and mufflers 4120, e.g., an inlet air filter 4112, an inletmuffler 4122, a pressure generator 4140 capable of supplying air atpositive pressure (e.g., a blower 4142), an outlet muffler 4124 and oneor more transducers 4270, such as pressure sensors and flow ratesensors.

One or more of the air path items may be located within a removableunitary structure which will be referred to as a pneumatic block 4020.The pneumatic block 4020 may be located within the external housing4010. In one form a pneumatic block 4020 is supported by, or formed aspart of the chassis 4016.

The RPT device 4000 may have an electrical power supply 4210, one ormore input devices 4220, a central controller 4230, a therapy devicecontroller 4240, a pressure generator 4140, one or more protectioncircuits 4250, memory 4260, transducers 4270, data communicationinterface 4280 and one or more output devices 4290. Electricalcomponents 4200 may be mounted on a single Printed Circuit BoardAssembly (PCBA) 4202. In an alternative form, the RPT device 4000 mayinclude more than one PCBA 4202.

5.5.1 RPT Device Mechanical & Pneumatic Components

An RPT device may comprise one or more of the following components in anintegral unit. In an alternative form, one or more of the followingcomponents may be located as respective separate units.

5.5.1.1 Air Filter(s)

An RPT device in accordance with one form of the present technology mayinclude an air filter 4110, or a plurality of air filters 4110.

In one form, an inlet air filter 4112 is located at the beginning of thepneumatic path upstream of a pressure generator 4140. See FIG. 4B.

In one form, an outlet air filter 4114, for example an antibacterialfilter, is located between an outlet of the pneumatic block 4020 and apatient interface 3000. See FIG. 4B.

5.5.1.2 Muffler(s)

In one form of the present technology, an inlet muffler 4122 is locatedin the pneumatic path upstream of a pressure generator 4140. See FIG.4B.

In one form of the present technology, an outlet muffler 4124 is locatedin the pneumatic path between the pressure generator 4140 and a patientinterface 3000. See FIG. 4B.

5.5.1.3 Pressure Generator

In one form of the present technology, a pressure generator 4140 forproducing a flow, or a supply, of air at positive pressure is acontrollable blower 4142. For example the blower 4142 may include abrushless DC motor 4144 with one or more impellers housed in a volute.The blower may be capable of delivering a supply of air, for example ata rate of up to about 120 litres/minute, at a positive pressure in arange from about 4 cmH₂O to about 20 cmH₂O, or in other forms up toabout 30 cmH₂O. The blower may be as described in any one of thefollowing patents or patent applications the contents of which areincorporated herein by reference in their entirety: U.S. Pat. Nos.7,866,944; 8,638,014; 8,636,479; and PCT Patent Application PublicationNo. WO 2013/020167.

The pressure generator 4140 is under the control of the therapy devicecontroller 4240.

In other forms, a pressure generator 4140 may be a piston-driven pump, apressure regulator connected to a high pressure source (e.g. compressedair reservoir), or a bellows.

5.5.1.4 Transducer(s)

Transducers may be internal of the RPT device, or external of the RPTdevice. External transducers may be located for example on or form partof the air circuit, e.g., the patient interface. External transducersmay be in the form of non-contact sensors such as a Doppler radarmovement sensor that transmit or transfer data to the RPT device.

In one form of the present technology, one or more transducers 4270 arelocated upstream and/or downstream of the pressure generator 4140. Theone or more transducers 4270 may be constructed and arranged to measureproperties such as a flow rate, a pressure or a temperature at thatpoint in the pneumatic path.

In one form of the present technology, one or more transducers 4270 maybe located proximate to the patient interface 3000.

In one form, a signal from a transducer 4270 may be filtered, such as bylow-pass, high-pass or band-pass filtering.

5.5.1.4.1 Flow Rate Sensor

A flow rate sensor in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION.

In one form, a signal representing a flow rate such as a total flow rateQt from the flow rate sensor is received by the central controller 4230.

5.5.1.4.2 Pressure Sensor

A pressure sensor in accordance with the present technology is locatedin fluid communication with the pneumatic path. An example of a suitablepressure transducer is a sensor from the HONEYWELL ASDX series. Analternative suitable pressure transducer is a sensor from the NPA Seriesfrom GENERAL ELECTRIC.

In one form, a signal from the pressure sensor is received by thecentral controller 4230.

5.5.1.4.3 Motor Speed Transducer

In one form of the present technology a motor speed transducer is usedto determine a rotational velocity of the motor 4144 and/or the blower4142. A motor speed signal from the motor speed transducer may beprovided to the therapy device controller 4240. The motor speedtransducer may, for example, be a speed sensor, such as a Hall effectsensor.

5.5.1.5 Anti-Spill Back Valve

In one form of the present technology, an anti-spill back valve 4160 islocated between the humidifier 5000 and the pneumatic block 4020. Theanti-spill back valve 4160 is constructed and arranged to reduce therisk that water will flow upstream from the humidifier 5000, for exampleto the motor 4144.

5.5.1.6 Air Circuit

An air circuit 4170 in accordance with an aspect of the presenttechnology is a conduit or a tube constructed and arranged in use toallow a flow of air to travel between two components such as thepneumatic block 4020 and the patient interface 3000.

In particular, the air circuit 4170 may be in fluid connection with theoutlet of the pneumatic block and the patient interface. The air circuitmay be referred to as an air delivery tube. In some cases there may beseparate limbs of the circuit for inhalation and exhalation. In othercases a single limb is used.

In some forms, the air circuit 4170 may comprise one or more heatingelements configured to heat air in the air circuit, for example tomaintain or raise the temperature of the air. In other words, the aircircuit 4170 may be a heated air circuit 4171. The heating element maybe in a form of a heated wire circuit, and may comprise one or moretransducers, such as temperature sensors. In one form, the heated wirecircuit may be helically wound around the axis of the air circuit 4170.The heating element may be in communication with a controller such as acentral controller 4230. One example of an air circuit 4170 comprising aheated wire circuit is described in United States Patent Application No.US/2011/0023874, which is incorporated herewithin in its entirety byreference.

FIGS. 36A to 36C depict examples of an air circuit 4170 according to anexample of the present technology. The air circuit 4170 may include atube 4172 that is comprised of one or more helical coils. The aircircuit 4173 may include an RPT device connector 4173 at one end that isconfigured to connect to an RPT device 4000 to receive the flow ofpressurized gas. At the other end, the air circuit 4170 may include avent adaptor connector 4174 that may be connected to a vent adaptor9100, such as in the examples disclosed in FIGS. 33A to 34G. The ventadaptor connector 4174 may include connectors 4175 to join withcorresponding air circuit connectors 9302 of the vent adaptor 9300. Theconnectors 4175 may be in the form of female bayonet connectors thatcorrespond to the air circuit connectors 9302. The vent adaptorconnector 4174 may also include grip recesses 4176 to allow the patientto grip the vent adaptor connector 4174 to rotate the air circuit 4170to connect to or disconnect from the vent adaptor 9100. The vent adaptorconnector 4174 may also include a seal 4177 to form a pneumatic sealbetween the vent adaptor connector 4174 and a tube connector 4178 thatconnects the vent adaptor connector 4174 to the tube 4172.

5.5.1.7 Oxygen Delivery

In one form of the present technology, supplemental oxygen 4180 isdelivered to one or more points in the pneumatic path, such as upstreamof the pneumatic block 4020, to the air circuit 4170 and/or to thepatient interface 3000.

5.5.2 RPT Device Electrical Components

5.5.2.1 Power Supply

A power supply 4210 may be located internal or external of the externalhousing 4010 of the RPT device 4000.

In one form of the present technology, power supply 4210 provideselectrical power to the RPT device 4000 only. In another form of thepresent technology, power supply 4210 provides electrical power to bothRPT device 4000 and humidifier 5000.

5.5.2.2 Input Devices

In one form of the present technology, an RPT device 4000 includes oneor more input devices 4220 in the form of buttons, switches or dials toallow a person to interact with the device. The buttons, switches ordials may be physical devices, or software devices accessible via atouch screen. The buttons, switches or dials may, in one form, bephysically connected to the external housing 4010, or may, in anotherform, be in wireless communication with a receiver that is in electricalconnection to the central controller 4230.

In one form, the input device 4220 may be constructed and arranged toallow a person to select a value and/or a menu option.

5.5.2.3 Central Controller

In one form of the present technology, the central controller 4230 isone or a plurality of processors suitable to control an RPT device 4000.

Suitable processors may include an x86 INTEL processor, a processorbased on ARM® Cortex®-M processor from ARM Holdings such as an STM32series microcontroller from ST MICROELECTRONIC. In certain alternativeforms of the present technology, a 32-bit RISC CPU, such as an STR9series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPUsuch as a processor from the MSP430 family of microcontrollers,manufactured by TEXAS INSTRUMENTS may also be suitable.

In one form of the present technology, the central controller 4230 is adedicated electronic circuit.

In one form, the central controller 4230 is an application-specificintegrated circuit. In another form, the central controller 4230comprises discrete electronic components.

The central controller 4230 may be configured to receive input signal(s)from one or more transducers 4270, one or more input devices 4220, andthe humidifier 5000.

The central controller 4230 may be configured to provide outputsignal(s) to one or more of an output device 4290, a therapy devicecontroller 4240, a data communication interface 4280, and the humidifier5000.

In some forms of the present technology, the central controller 4230 isconfigured to implement the one or more methodologies described herein,such as the one or more algorithms 4300 expressed as computer programsstored in a non-transitory computer readable storage medium, such asmemory 4260. In some forms of the present technology, the centralcontroller 4230 may be integrated with an RPT device 4000. However, insome forms of the present technology, some methodologies may beperformed by a remotely located device. For example, the remotelylocated device may determine control settings for a ventilator or detectrespiratory related events by analysis of stored data such as from anyof the sensors described herein.

5.5.2.4 Clock

The RPT device 4000 may include a clock that is connected to the centralcontroller 4230.

5.5.2.5 Therapy Device Controller

In one form of the present technology, a therapy device 4350 may includea therapy device controller 4240 is a therapy control module 4330 thatforms part of the algorithms 4300 executed by the central controller4230.

In one form of the present technology, therapy device controller 4240 isa dedicated motor control integrated circuit. For example, in one form aMC33035 brushless DC motor controller, manufactured by ONSEMI is used.

5.5.2.6 Protection Circuits

The one or more protection circuits 4250 in accordance with the presenttechnology may comprise an electrical protection circuit, a temperatureand/or pressure safety circuit.

5.5.2.7 Memory

In accordance with one form of the present technology the RPT device4000 includes memory 4260, e.g., non-volatile memory. In some forms,memory 4260 may include battery powered static RAM. In some forms,memory 4260 may include volatile RAM.

Memory 4260 may be located on the PCBA 4202. Memory 4260 may be in theform of EEPROM, or NAND flash.

Additionally or alternatively, RPT device 4000 includes a removable formof memory 4260, for example a memory card made in accordance with theSecure Digital (SD) standard.

In one form of the present technology, the memory 4260 acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms 4300.

5.5.2.8 Data Communication Systems

In one form of the present technology, a data communication interface4280 is provided, and is connected to the central controller 4230. Datacommunication interface 4280 may be connectable to a remote externalcommunication network and/or a local external communication network. Theremote external communication network may be connectable to a remoteexternal device. The local external communication network may beconnectable to a local external device.

In one form, data communication interface 4280 is part of the centralcontroller 4230. In another form, data communication interface 4280 isseparate from the central controller 4230, and may comprise anintegrated circuit or a processor.

In one form, remote external communication network is the Internet. Thedata communication interface 4280 may use wired communication (e.g. viaEthernet, or optical fibre) or a wireless protocol (e.g. CDMA, GSM, LTE)to connect to the Internet.

In one form, local external communication network utilises one or morecommunication standards, such as Bluetooth, or a consumer infraredprotocol.

In one form, remote external device is one or more computers, forexample a cluster of networked computers. In one form, remote externaldevice may be virtual computers, rather than physical computers. Ineither case, such a remote external device may be accessible to anappropriately authorised person such as a clinician.

The local external device may be a personal computer, mobile phone,tablet or remote control.

5.5.2.9 Output Devices Including Optional Display, Alarms

An output device 4290 in accordance with the present technology may takethe form of one or more of a visual, audio and haptic unit. A visualdisplay may be a Liquid Crystal Display (LCD) or Light Emitting Diode(LED) display.

5.5.2.9.1 Display Driver

A display driver receives as an input the characters, symbols, or imagesintended for display on the display, and converts them to commands thatcause the display to display those characters, symbols, or images.

5.5.2.9.2 Display

A display is configured to visually display characters, symbols, orimages in response to commands received from the display driver. Forexample, the display may be an eight-segment display, in which case thedisplay driver converts each character or symbol, such as the figure“0”, to eight logical signals indicating whether the eight respectivesegments are to be activated to display a particular character orsymbol.

5.5.3 RPT Device Algorithms

5.5.3.1 Pre-Processing Module

A pre-processing module 4310 in accordance with one form of the presenttechnology receives as an input a signal from a transducer 4270, forexample a flow rate sensor or pressure sensor, and performs one or moreprocess steps to calculate one or more output values that will be usedas an input to another module, for example a therapy engine module 4320.

In one form of the present technology, the output values include theinterface or mask pressure Pm, the respiratory flow rate Qr, and theleak flow rate Ql.

In various forms of the present technology, the pre-processing module4310 comprises one or more of the following algorithms—pressurecompensation 4312, vent flow rate estimation 4314, leak flow rateestimation 4316, and respiratory flow rate estimation 4318.

5.5.3.1.1 Pressure Compensation

In one form of the present technology, a pressure compensation algorithm4312 receives as an input a signal indicative of the pressure in thepneumatic path proximal to an outlet of the pneumatic block. Thepressure compensation algorithm 4312 estimates the pressure drop throughthe air circuit 4170 and provides as an output an estimated pressure,Pm, in the patient interface 3000.

5.5.3.1.2 Vent Flow Rate Estimation

In one form of the present technology, a vent flow rate estimationalgorithm 4314 receives as an input an estimated pressure, Pm, in thepatient interface 3000 and estimates a vent flow rate of air, Qv, from avent 3400 in a patient interface 3000.

5.5.3.1.3 Leak Flow Rate Estimation

In one form of the present technology, a leak flow rate estimationalgorithm 4316 receives as an input a total flow rate, Qt, and a ventflow rate Qv, and provides as an output an estimate of the leak flowrate, Ql. In one form, the leak flow rate estimation algorithm estimatesthe leak flow rate Ql by calculating an average of the differencebetween total flow rate Qt and vent flow rate Qv over a periodsufficiently long to include several breathing cycles, e.g. about 10seconds.

In one form, the leak flow rate estimation algorithm 4316 receives as aninput a total flow rate Qt, a vent flow rate Qv, and an estimatedpressure, Pm, in the patient interface 3000, and provides as an output aleak flow rate Ql, by calculating a leak conductance, and determining aleak flow rate Ql to be a function of leak conductance and pressure, Pm.Leak conductance is calculated as the quotient of low pass filterednon-vent flow rate equal to the difference between total flow rate Qtand vent flow rate Qv, and low pass filtered square root of pressure Pm,where the low pass filter time constant has a value sufficiently long toinclude several breathing cycles, e.g. about 10 seconds. The leak flowrate Ql may be estimated as the product of leak conductance and afunction of pressure, Pm.

5.5.3.1.4 Respiratory Flow Rate Estimation

In one form of the present technology, a respiratory flow rateestimation algorithm 4318 receives as an input a total flow rate, Qt, avent flow rate, Qv, and a leak flow rate, Ql, and estimates arespiratory flow rate of air, Qr, to the patient, by subtracting thevent flow rate Qv and the leak flow rate Ql from the total flow rate Qt.

5.5.3.2 Therapy Engine Module

In one form of the present technology, a therapy engine module 4320receives as inputs one or more of a pressure, Pm, in a patient interface3000, and a respiratory flow rate of air to a patient, Qr, and providesas an output one or more therapy parameters.

In one form of the present technology, a therapy parameter is atreatment pressure Pt.

In one form of the present technology, therapy parameters are one ormore of a level of pressure support, a base pressure, and a targetventilation.

In various forms, the therapy engine module 4320 comprises one or moreof the following algorithms: phase determination 4321, waveformdetermination 4322, ventilation determination 4323, inspiratory flowlimitation determination 4324, apnea/hypopnea determination 4325, snoredetermination 4326, airway patency determination 4327, targetventilation determination 4328, and therapy parameter determination4329.

5.5.3.2.1 Phase Determination

In one form of the present technology, the RPT device 4000 does notdetermine phase.

In one form of the present technology, a phase determination algorithm4321 receives as an input a signal indicative of respiratory flow rate,Qr, and provides as an output a phase Φ of a current breathing cycle ofa patient 1000.

In some forms, known as discrete phase determination, the phase output Φis a discrete variable. One implementation of discrete phasedetermination provides a bi-valued phase output Φ with values of eitherinhalation or exhalation, for example represented as values of 0 and 0.5revolutions respectively, upon detecting the start of spontaneousinhalation and exhalation respectively. RPT devices 4000 that “trigger”and “cycle” effectively perform discrete phase determination, since thetrigger and cycle points are the instants at which the phase changesfrom exhalation to inhalation and from inhalation to exhalation,respectively. In one implementation of bi-valued phase determination,the phase output Φ is determined to have a discrete value of 0 (thereby“triggering” the RPT device 4000) when the respiratory flow rate Qr hasa value that exceeds a positive threshold, and a discrete value of 0.5revolutions (thereby “cycling” the RPT device 4000) when a respiratoryflow rate Qr has a value that is more negative than a negativethreshold.

Another implementation of discrete phase determination provides atri-valued phase output Φ with a value of one of inhalation,mid-inspiratory pause, and exhalation.

In other forms, known as continuous phase determination, the phaseoutput Φ is a continuous variable, for example varying from 0 to 1revolutions, or 0 to 2π radians. RPT devices 4000 that performcontinuous phase determination may trigger and cycle when the continuousphase reaches 0 and 0.5 revolutions, respectively. In one implementationof continuous phase determination, a continuous value of phase Φ isdetermined using a fuzzy logic analysis of the respiratory flow rate Qr.A continuous value of phase determined in this implementation is oftenreferred to as “fuzzy phase”. In one implementation of a fuzzy phasedetermination algorithm 4321, the following rules are applied to therespiratory flow rate Qr:

-   -   1. If the respiratory flow rate is zero and increasing fast then        the phase is 0 revolutions.    -   2. If the respiratory flow rate is large positive and steady        then the phase is 0.25 revolutions.    -   3. If the respiratory flow rate is zero and falling fast, then        the phase is 0.5 revolutions.    -   4. If the respiratory flow rate is large negative and steady        then the phase is 0.75 revolutions.    -   5. If the respiratory flow rate is zero and steady and the        5-second low-pass filtered absolute value of the respiratory        flow rate is large then the phase is 0.9 revolutions.    -   6. If the respiratory flow rate is positive and the phase is        expiratory, then the phase is 0 revolutions.    -   7. If the respiratory flow rate is negative and the phase is        inspiratory, then the phase is 0.5 revolutions.    -   8. If the 5-second low-pass filtered absolute value of the        respiratory flow rate is large, the phase is increasing at a        steady rate equal to the patient's breathing rate, low-pass        filtered with a time constant of 20 seconds.

The output of each rule may be represented as a vector whose phase isthe result of the rule and whose magnitude is the fuzzy extent to whichthe rule is true. The fuzzy extent to which the respiratory flow rate is“large”, “steady”, etc. is determined with suitable membershipfunctions. The results of the rules, represented as vectors, are thencombined by some function such as taking the centroid. In such acombination, the rules may be equally weighted, or differently weighted.

In another implementation of continuous phase determination, theinhalation time Ti and the exhalation time Te are first estimated fromthe respiratory flow rate Qr. The phase Φ is then determined as the halfthe proportion of the inhalation time Ti that has elapsed since theprevious trigger instant, or 0.5 revolutions plus half the proportion ofthe exhalation time Te that has elapsed since the previous cycle instant(whichever was more recent).

5.5.3.2.2 Waveform Determination

In one form of the present technology, the therapy parameterdetermination algorithm 4329 provides an approximately constanttreatment pressure throughout a respiratory cycle of a patient.

In other forms of the present technology, the therapy parameterdetermination algorithm 4329 controls the pressure generator 4140 toprovide a treatment pressure Pt that varies throughout a respiratorycycle of a patient according to a waveform template.

In one form of the present technology, a waveform determinationalgorithm 4322 provides a waveform template Π(Φ) with values in therange [0, 1] on the domain of phase values Φ provided by the phasedetermination algorithm 4321 to be used by the therapy parameterdetermination algorithm 4329.

In one form, suitable for either discrete or continuously-valued phase,the waveform template Π(Φ) is a square-wave template, having a value of1 for values of phase up to and including 0.5 revolutions, and a valueof 0 for values of phase above 0.5 revolutions. In one form, suitablefor continuously-valued phase, the waveform template Π(Φ) comprises twosmoothly curved portions, namely a smoothly curved (e.g. raised cosine)rise from 0 to 1 for values of phase up to 0.5 revolutions, and asmoothly curved (e.g. exponential) decay from 1 to 0 for values of phaseabove 0.5 revolutions. In one form, suitable for continuously-valuedphase, the waveform template Π(Φ) is based on a square wave, but with asmooth rise from 0 to 1 for values of phase up to a “rise time” that issubstantially less than 0.5 revolutions, and a smooth fall from 1 to 0for values of phase within a “fall time” after 0.5 revolutions.

In some forms of the present technology, the waveform determinationalgorithm 4322 selects a waveform template Π(Φ) from a library ofwaveform templates, dependent on a setting of the RPT device. Eachwaveform template Π(Φ) in the library may be provided as a lookup tableof values II against phase values Φ. In other forms, the waveformdetermination algorithm 4322 computes a waveform template Π(Φ) “on thefly” using a predetermined functional form, possibly parametrised by oneor more parameters (e,g. time constant of an exponentially curvedportion). The parameters of the functional form may be predetermined ordependent on a current state of the patient 1000.

In some forms of the present technology, suitable for discrete bi-valuedphase of either inhalation (Φ=0 revolutions) or exhalation (Φ=0.5revolutions), the waveform determination algorithm 4322 computes awaveform template Π “on the fly” as a function of both discrete phase Φand time t measured since the most recent trigger instant. In one suchform, the waveform determination algorithm 4322 computes the waveformtemplate Π(Φ, t) in two portions (inspiratory and expiratory) asfollows:

${\prod\left( {\Phi,t} \right)} = \left\{ \begin{matrix}{{\prod\limits_{i}(t)},} & {\Phi = 0} \\{{\prod\limits_{e}\left( {t - T_{i}} \right)},} & {\Phi = 0.5}\end{matrix} \right.$

where Π_(i)(t) and Π_(e)(t) are inspiratory and expiratory portions ofthe waveform template Π(Φ, t). In one such form, the inspiratory portionΠ_(i)(t) of the waveform template is a smooth rise from 0 to 1parametrised by a rise time, and the expiratory portion Π_(e)(t) of thewaveform template is a smooth fall from 1 to 0 parametrised by a falltime.

5.5.3.2.3 Ventilation Determination

In one form of the present technology, a ventilation determinationalgorithm 4323 receives an input a respiratory flow rate Qr, anddetermines a measure indicative of current patient ventilation, Vent.

In some implementations, the ventilation determination algorithm 4323determines a measure of ventilation Vent that is an estimate of actualpatient ventilation. One such implementation is to take half theabsolute value of respiratory flow rate, Qr, optionally filtered bylow-pass filter such as a second order Bessel low-pass filter with acorner frequency of 0.11 Hz.

In other implementations, the ventilation determination algorithm 4323determines a measure of ventilation Vent that is broadly proportional toactual patient ventilation. One such implementation estimates peakrespiratory flow rate Qpeak over the inspiratory portion of the cycle.This and many other procedures involving sampling the respiratory flowrate Qr produce measures which are broadly proportional to ventilation,provided the flow rate waveform shape does not vary very much (here, theshape of two breaths is taken to be similar when the flow rate waveformsof the breaths normalised in time and amplitude are similar). Somesimple examples include the median positive respiratory flow rate, themedian of the absolute value of respiratory flow rate, and the standarddeviation of flow rate. Arbitrary linear combinations of arbitrary orderstatistics of the absolute value of respiratory flow rate using positivecoefficients, and even some using both positive and negativecoefficients, are approximately proportional to ventilation. Anotherexample is the mean of the respiratory flow rate in the middle Kproportion (by time) of the inspiratory portion, where 0<K<1. There isan arbitrarily large number of measures that are exactly proportional toventilation if the flow rate shape is constant.

5.5.3.2.4 Determination of Inspiratory Flow Limitation

In one form of the present technology, the central controller 4230executes an inspiratory flow limitation determination algorithm 4324 forthe determination of the extent of inspiratory flow limitation.

In one form, the inspiratory flow limitation determination algorithm4324 receives as an input a respiratory flow rate signal Qr and providesas an output a metric of the extent to which the inspiratory portion ofthe breath exhibits inspiratory flow limitation.

In one form of the present technology, the inspiratory portion of eachbreath is identified by a zero-crossing detector. A number of evenlyspaced points (for example, sixty-five), representing points in time,are interpolated by an interpolator along the inspiratory flow rate-timecurve for each breath. The curve described by the points is then scaledby a scaler to have unity length (duration/period) and unity area toremove the effects of changing breathing rate and depth. The scaledbreaths are then compared in a comparator with a pre-stored templaterepresenting a normal unobstructed breath, similar to the inspiratoryportion of the breath shown in FIG. 6A. Breaths deviating by more than aspecified threshold (typically 1 scaled unit) at any time during theinspiration from this template, such as those due to coughs, sighs,swallows and hiccups, as determined by a test element, are rejected. Fornon-rejected data, a moving average of the first such scaled point iscalculated by the central controller 4230 for the preceding severalinspiratory events. This is repeated over the same inspiratory eventsfor the second such point, and so on. Thus, for example, sixty fivescaled data points are generated by the central controller 4230, andrepresent a moving average of the preceding several inspiratory events,e.g., three events. The moving average of continuously updated values ofthe (e.g., sixty five) points are hereinafter called the “scaled flowrate”, designated as Qs(t). Alternatively, a single inspiratory eventcan be utilised rather than a moving average.

From the scaled flow rate, two shape factors relating to thedetermination of partial obstruction may be calculated.

Shape factor 1 is the ratio of the mean of the middle (e.g. thirty-two)scaled flow rate points to the mean overall (e.g. sixty-five) scaledflow rate points. Where this ratio is in excess of unity, the breathwill be taken to be normal. Where the ratio is unity or less, the breathwill be taken to be obstructed. A ratio of about 1.17 is taken as athreshold between partially obstructed and unobstructed breathing, andequates to a degree of obstruction that would permit maintenance ofadequate oxygenation in a typical patient.

Shape factor 2 is calculated as the RMS deviation from unit scaled flowrate, taken over the middle (e.g. thirty two) points. An RMS deviationof about 0.2 units is taken to be normal. An RMS deviation of zero istaken to be a totally flow—limited breath. The closer the RMS deviationto zero, the breath will be taken to be more flow limited.

Shape factors 1 and 2 may be used as alternatives, or in combination. Inother forms of the present technology, the number of sampled points,breaths and middle points may differ from those described above.Furthermore, the threshold values can other than those described.

5.5.3.2.5 Determination of Apneas and Hypopneas

In one form of the present technology, the central controller 4230executes an apnea/hypopnea determination algorithm 4325 for thedetermination of the presence of apneas and/or hypopneas.

The apnea/hypopnea determination algorithm 4325 receives as an input arespiratory flow rate signal Qr and provide as an output a flag thatindicates that an apnea or a hypopnea has been detected.

In one form, an apnea will be said to have been detected when a functionof respiratory flow rate Qr falls below a flow rate threshold for apredetermined period of time. The function may determine a peak flowrate, a relatively short-term mean flow rate, or a flow rateintermediate of relatively short-term mean and peak flow rate, forexample an RMS flow rate. The flow rate threshold may be a relativelylong-term measure of flow rate.

In one form, a hypopnea will be said to have been detected when afunction of respiratory flow rate Qr falls below a second flow ratethreshold for a predetermined period of time. The function may determinea peak flow, a relatively short-term mean flow rate, or a flow rateintermediate of relatively short-term mean and peak flow rate, forexample an RMS flow rate. The second flow rate threshold may be arelatively long-term measure of flow rate. The second flow ratethreshold is greater than the flow rate threshold used to detect apneas.

5.5.3.2.6 Determination of Snore

In one form of the present technology, the central controller 4230executes one or more snore determination algorithms 4326 for thedetermination of the extent of snore.

In one form, the snore determination algorithm 4326 receives as an inputa respiratory flow rate signal Qr and provides as an output a metric ofthe extent to which snoring is present.

The snore determination algorithm 4326 may comprise the step ofdetermining the intensity of the flow rate signal in the range of 30-300Hz. Further the snore determination algorithm 4326 may comprise a stepof filtering the respiratory flow rate signal Qr to reduce backgroundnoise, e.g., the sound of airflow in the system from the blower.

5.5.3.2.7 Determination of Airway Patency

In one form of the present technology, the central controller 4230executes one or more airway patency determination algorithms 4327 forthe determination of the extent of airway patency.

In one form, the airway patency determination algorithm 4327 receives asan input a respiratory flow rate signal Qr, and determines the power ofthe signal in the frequency range of about 0.75 Hz and about 3 Hz. Thepresence of a peak in this frequency range is taken to indicate an openairway. The absence of a peak is taken to be an indication of a closedairway.

In one form, the frequency range within which the peak is sought is thefrequency of a small forced oscillation in the treatment pressure Pt. Inone implementation, the forced oscillation is of frequency 2 Hz withamplitude about 1 cmH₂O.

In one form, airway patency determination algorithm 4327 receives as aninput a respiratory flow rate signal Qr, and determines the presence orabsence of a cardiogenic signal. The absence of a cardiogenic signal istaken to be an indication of a closed airway.

5.5.3.2.8 Determination of Target Ventilation

In one form of the present technology, the central controller 4230 takesas input the measure of current ventilation, Vent, and executes one ormore a target ventilation determination algorithms 4328 for thedetermination of a target value Vtgt for the measure of ventilation.

In some forms of the present technology, there is no target ventilationdetermination algorithm 4328, and the target value Vtgt ispredetermined, for example by hard-coding during configuration of theRPT device 4000 or by manual entry through the input device 4220.

In other forms of the present technology, such as adaptiveservo-ventilation (ASV), the target ventilation determination algorithm4328 computes a target value Vtgt from a value Vtyp indicative of thetypical recent ventilation of the patient.

In some forms of adaptive servo-ventilation, the target ventilation Vtgtis computed as a high proportion of, but less than, the typical recentventilation Vtyp. The high proportion in such forms may be in the range(80%, 100%), or (85%, 95%), or (87%, 92%).

In other forms of adaptive servo-ventilation, the target ventilationVtgt is computed as a slightly greater than unity multiple of thetypical recent ventilation Vtyp.

The typical recent ventilation Vtyp is the value around which thedistribution of the measure of current ventilation Vent over multipletime instants over some predetermined timescale tends to cluster, thatis, a measure of the central tendency of the measure of currentventilation over recent history. In one implementation of the targetventilation determination algorithm 4328, the recent history is of theorder of several minutes, but in any case should be longer than thetimescale of Cheyne-Stokes waxing and waning cycles. The targetventilation determination algorithm 4328 may use any of the variety ofwell-known measures of central tendency to determine the typical recentventilation Vtyp from the measure of current ventilation, Vent. One suchmeasure is the output of a low-pass filter on the measure of currentventilation Vent, with time constant equal to one hundred seconds.

5.5.3.2.9 Determination of Therapy Parameters

In some forms of the present technology, the central controller 4230executes one or more therapy parameter determination algorithms 4329 forthe determination of one or more therapy parameters using the valuesreturned by one or more of the other algorithms in the therapy enginemodule 4320.

In one form of the present technology, the therapy parameter is aninstantaneous treatment pressure Pt. In one implementation of this form,the therapy parameter determination algorithm 4329 determines thetreatment pressure Pt using the equationPt=AΠ(Φ,t)+P ₀  (1)

where:

-   -   A is the amplitude,    -   Π(Φ, t) is the waveform template value (in the range 0 to 1) at        the current value Φ of phase and t of time, and    -   P₀ is a base pressure.

If the waveform determination algorithm 4322 provides the waveformtemplate Π(Φ, t) as a lookup table of values indexed by phase Φ, thetherapy parameter determination algorithm 4329 applies equation (1) bylocating the nearest lookup table entry to the current value Φ of phasereturned by the phase determination algorithm 4321, or by interpolationbetween the two entries straddling the current value Φ of phase.

The values of the amplitude A and the base pressure P₀ may be set by thetherapy parameter determination algorithm 4329 depending on the chosenrespiratory pressure therapy mode in the manner described below.

5.5.3.3 Therapy Control Module

Therapy control module 4330 in accordance with one aspect of the presenttechnology receives as inputs the therapy parameters from the therapyparameter determination algorithm 4329 of the therapy engine module4320, and controls the pressure generator 4140 to deliver a flow of airin accordance with the therapy parameters.

In one form of the present technology, the therapy parameter is atreatment pressure Pt, and the therapy control module 4330 controls thepressure generator 4140 to deliver a flow of air whose mask pressure Pmat the patient interface 3000 is equal to the treatment pressure Pt.

5.5.3.4 Detection of Fault Conditions

In one form of the present technology, the central controller 4230executes one or more methods for the detection of fault conditions 4340.The fault conditions detected by the one or more methods may include atleast one of the following:

-   -   Power failure (no power, or insufficient power)    -   Transducer fault detection    -   Failure to detect the presence of a component    -   Operating parameters outside recommended ranges (e.g. pressure,        flow rate, temperature, PaO₂)    -   Failure of a test alarm to generate a detectable alarm signal.

Upon detection of the fault condition, the corresponding algorithmsignals the presence of the fault by one or more of the following:

-   -   Initiation of an audible, visual &/or kinetic (e.g. vibrating)        alarm    -   Sending a message to an external device    -   Logging of the incident        5.6 Humidifier        5.6.1 Humidifier Overview

In one form of the present technology there is provided a humidifier5000 (e.g. as shown in FIG. 5A) to change the absolute humidity of airor gas for delivery to a patient relative to ambient air. Typically, thehumidifier 5000 is used to increase the absolute humidity and increasethe temperature of the flow of air (relative to ambient air) beforedelivery to the patient's airways.

The humidifier 5000 may comprise a humidifier reservoir 5110, ahumidifier inlet 5002 to receive a flow of air, and a humidifier outlet5004 to deliver a humidified flow of air. In some forms, as shown inFIG. 5A and FIG. 5B, an inlet and an outlet of the humidifier reservoir5110 may be the humidifier inlet 5002 and the humidifier outlet 5004respectively. The humidifier 5000 may further comprise a humidifier base5006, which may be adapted to receive the humidifier reservoir 5110 andcomprise a heating element 5240.

5.6.2 Humidifier Mechanical Components

5.6.2.1 Water Reservoir

According to one arrangement, the humidifier 5000 may comprise a waterreservoir 5110 configured to hold, or retain, a volume of liquid (e.g.water) to be evaporated for humidification of the flow of air. The waterreservoir 5110 may be configured to hold a predetermined maximum volumeof water in order to provide adequate humidification for at least theduration of a respiratory therapy session, such as one evening of sleep.Typically, the reservoir 5110 is configured to hold several hundredmillilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400ml. In other forms, the humidifier 5000 may be configured to receive asupply of water from an external water source such as a building's watersupply system.

According to one aspect, the water reservoir 5110 is configured to addhumidity to a flow of air from the RPT device 4000 as the flow of airtravels therethrough. In one form, the water reservoir 5110 may beconfigured to encourage the flow of air to travel in a tortuous paththrough the reservoir 5110 while in contact with the volume of watertherein.

According to one form, the reservoir 5110 may be removable from thehumidifier 5000, for example in a lateral direction as shown in FIG. 5Aand FIG. 5B.

The reservoir 5110 may also be configured to discourage egress of liquidtherefrom, such as when the reservoir 5110 is displaced and/or rotatedfrom its normal, working orientation, such as through any aperturesand/or in between its sub-components. As the flow of air to behumidified by the humidifier 5000 is typically pressurised, thereservoir 5110 may also be configured to prevent losses in pneumaticpressure through leak and/or flow impedance.

5.6.2.2 Conductive Portion

According to one arrangement, the reservoir 5110 comprises a conductiveportion 5120 configured to allow efficient transfer of heat from theheating element 5240 to the volume of liquid in the reservoir 5110. Inone form, the conductive portion 5120 may be arranged as a plate,although other shapes may also be suitable. All or a part of theconductive portion 5120 may be made of a thermally conductive materialsuch as aluminium (e.g. approximately 2 mm thick, such as 1 mm, 1.5 mm,2.5 mm or 3 mm), another heat conducting metal or some plastics. In somecases, suitable heat conductivity may be achieved with less conductivematerials of suitable geometry.

5.6.2.3 Humidifier Reservoir Dock

In one form, the humidifier 5000 may comprise a humidifier reservoirdock 5130 (as shown in FIG. 5B) configured to receive the humidifierreservoir 5110. In some arrangements, the humidifier reservoir dock 5130may comprise a locking feature such as a locking lever 5135 configuredto retain the reservoir 5110 in the humidifier reservoir dock 5130.

5.6.2.4 Water Level Indicator

The humidifier reservoir 5110 may comprise a water level indicator 5150as shown in FIG. 5A-5B. In some forms, the water level indicator 5150may provide one or more indications to a user such as the patient 1000or a care giver regarding a quantity of the volume of water in thehumidifier reservoir 5110. The one or more indications provided by thewater level indicator 5150 may include an indication of a maximum,predetermined volume of water, any portions thereof, such as 25%, 50% or75% or volumes such as 200 ml, 300 ml or 400 ml.

5.6.3 Humidifier Electrical & Thermal Components

The humidifier 5000 may comprise a number of electrical and/or thermalcomponents such as those listed below.

5.6.3.1 Humidifier Transducer(s)

The humidifier 5000 may comprise one or more humidifier transducers(sensors) 5210 instead of, or in addition to, transducers 4270 describedabove. Humidifier transducers 5210 may include one or more of an airpressure sensor 5212, an air flow rate transducer 5214, a temperaturesensor 5216, or a humidity sensor 5218 as shown in FIG. 5C. A humidifiertransducer 5210 may produce one or more output signals which may becommunicated to a controller such as the central controller 4230 and/orthe humidifier controller 5250. In some forms, a humidifier transducermay be located externally to the humidifier 5000 (such as in the aircircuit 4170) while communicating the output signal to the controller.

5.6.3.1.1 Pressure Transducer

One or more pressure transducers 5212 may be provided to the humidifier5000 in addition to, or instead of, a pressure sensor provided in theRPT device 4000.

5.6.3.1.2 Flow Rate Transducer

One or more flow rate transducers 5214 may be provided to the humidifier5000 in addition to, or instead of, a flow rate sensor provided in theRPT device 4000.

5.6.3.1.3 Temperature Transducer

The humidifier 5000 may comprise one or more temperature transducers5216. The one or more temperature transducers 5216 may be configured tomeasure one or more temperatures such as of the heating element 5240and/or of the flow of air downstream of the humidifier outlet 5004. Insome forms, the humidifier 5000 may further comprise a temperaturesensor 5216 to detect the temperature of the ambient air.

5.6.3.1.4 Humidity Transducer

In one form, the humidifier 5000 may comprise one or more humiditysensors 5218 to detect a humidity of a gas, such as the ambient air. Thehumidity sensor 5218 may be placed towards the humidifier outlet 5004 insome forms to measure a humidity of the gas delivered from thehumidifier 5000. The humidity sensor may be an absolute humidity sensoror a relative humidity sensor.

5.6.3.2 Heating Element

A heating element 5240 may be provided to the humidifier 5000 in somecases to provide a heat input to one or more of the volume of water inthe humidifier reservoir 5110 and/or to the flow of air. The heatingelement 5240 may comprise a heat generating component such as anelectrically resistive heating track. One suitable example of a heatingelement 5240 is a layered heating element such as one described in thePCT Patent Application Publication No. WO 2012/171072, which isincorporated herewith by reference in its entirety.

In some forms, the heating element 5240 may be provided in thehumidifier base 5006 where heat may be provided to the humidifierreservoir 5110 primarily by conduction as shown in FIG. 5B.

5.6.3.3 Humidifier Controller

According to one arrangement of the present technology, a humidifier5000 may comprise a humidifier controller 5250 as shown in FIG. 5C. Inone form, the humidifier controller 5250 may be a part of the centralcontroller 4230. In another form, the humidifier controller 5250 may bea separate controller, which may be in communication with the centralcontroller 4230.

In one form, the humidifier controller 5250 may receive as inputsmeasures of characteristics (such as temperature, humidity, pressureand/or flow rate), for example of the flow of air, the water in thereservoir 5110 and/or the humidifier 5000. The humidifier controller5250 may also be configured to execute or implement humidifieralgorithms and/or deliver one or more output signals.

As shown in FIG. 5C, the humidifier controller 5250 may comprise one ormore controllers, such as a central humidifier controller 5251, a heatedair circuit controller 5254 configured to control the temperature of aheated air circuit 4170 and/or a heating element controller 5252configured to control the temperature of a heating element 5240.

5.7 Respiratory Pressure Therapy Modes

Various respiratory pressure therapy modes may be implemented by the RPTdevice 4000 depending on the values of the parameters A and P₀ in thetreatment pressure equation (1) used by the therapy parameterdetermination algorithm 4329 in one form of the present technology.

5.7.1 CPAP Therapy

In some implementations of this form of the present technology, theamplitude A is identically zero, so the treatment pressure Pt isidentically equal to the base pressure P₀ throughout the respiratorycycle. Such implementations are generally grouped under the heading ofCPAP therapy. In such implementations, there is no need for the therapyengine module 4320 to determine phase Φ or the waveform template Π(Φ).

In CPAP therapy modes, the base pressure P₀ may be a constant value thatis hard-coded or manually entered to the RPT device 4000. Thisalternative is sometimes referred to as constant CPAP therapy. Theconstant value for the base pressure P₀ may be selected for a givenpatient via a process known as titration. During titration, a cliniciantypically adjusts the treatment pressure Pt in response to observationsof flow limitation, apnea, hypopnea, patency, and snore during atitration session. The titrated base pressure P₀ may be then computed asa statistical summary of the treatment pressure Pt during the titrationsession.

Alternatively, the therapy parameter determination algorithm 4329 maycontinuously compute the base pressure P₀ during CPAP therapy. In thisalternative, the therapy parameter determination algorithm 4329continuously computes the base pressure P₀ as a function of indices ormeasures of sleep disordered breathing returned by the respectivealgorithms in the therapy engine module 4320, such as one or more offlow limitation, apnea, hypopnea, patency, and snore. This alternativeis sometimes referred to as APAP therapy. Because the continuouscomputation of the base pressure P₀ resembles the manual adjustment ofthe treatment pressure Pt by a clinician during titration, APAP therapyis also sometimes referred to as auto-titrating CPAP.

5.7.2 Bi-Level Therapy

In other implementations of this form of the present technology, thevalue of amplitude A in equation (1) may be positive. Suchimplementations are known as bi-level therapy, because in determiningthe treatment pressure Pt using equation (1) with positive amplitude A,the therapy parameter determination algorithm 4329 oscillates thetreatment pressure Pt between two values or levels in synchrony with thespontaneous respiratory effort of the patient 1000. That is, based onthe typical waveform templates Π(Φ, t) described above, the therapyparameter determination algorithm 4329 increases the treatment pressurePt to P₀+A (known as the IPAP) at the start of, or during, orinspiration and decreases the treatment pressure Pt to the base pressureP₀ (known as the EPAP) at the start of, or during, expiration.

In some forms of bi-level therapy, the IPAP is a prescribed treatmentpressure that has the same purpose as the treatment pressure in CPAPtherapy modes, and the EPAP is the IPAP minus the amplitude A, which hasa “small” value (a few cmH₂O) sometimes referred to as the ExpiratoryPressure Relief (EPR). Such forms are sometimes referred to as CPAPtherapy with EPR, which is generally thought to be more comfortable thanstraight CPAP therapy. In CPAP therapy with EPR, either or both of theIPAP and the EPAP may be constant values that are hard-coded or manuallyentered to the RPT device 4000. Alternatively, the therapy parameterdetermination algorithm 4329 may continuously compute the IPAP and/orthe EPAP during CPAP with EPR. In this alternative, the therapyparameter determination algorithm 4329 continuously computes the EPAPand/or the IPAP as a function of indices or measures of sleep disorderedbreathing returned by the respective algorithms in the therapy enginemodule 4320 is analogous fashion to the computation of the base pressureP₀ in APAP therapy described above.

In other forms of bi-level therapy, the amplitude A is large enough thatthe RPT device 4000 does some or all of the work of breathing of thepatient 1000. In such forms, known as pressure support ventilationtherapy, the amplitude A is referred to as the pressure support, orswing. In pressure support ventilation therapy, the IPAP is the basepressure P₀ plus the pressure support A, and the EPAP is the basepressure P₀.

In some forms of pressure support ventilation therapy, known as fixedpressure support ventilation therapy, the pressure support A is fixed ata predetermined value, e.g. 10 cmH₂O. The predetermined pressure supportvalue is a setting of the RPT device 4000, and may be set for example byhard-coding during configuration of the RPT device 4000 or by manualentry through the input device 4220.

In some forms of pressure support ventilation therapy, known asservo-ventilation, the therapy parameter determination algorithm 4329takes as input the current measure Vent of ventilation and the targetvalue Vtgt of ventilation provided by the target ventilationdetermination algorithm 4328 and continuously adjusts the parameters ofequation (1) to bring the current measure Vent of ventilation towardsthe target value Vtgt of ventilation. In a form of servo-ventilationknown as adaptive servo-ventilation (ASV), which has been used to treatCSR, the target ventilation Vtgt is computed by the target ventilationdetermination algorithm 4328 from the typical recent ventilation Vtyp,as described above.

In some forms of servo-ventilation, the therapy parameter determinationalgorithm 4329 applies a control methodology to continuously compute thepressure support A so as to bring the current measure Vent ofventilation towards the target ventilation Vtgt. One such controlmethodology is Proportional-Integral (PI) control. In one implementationof PI control, suitable for ASV modes in which a target ventilation Vtgtis set to slightly less than the typical recent ventilation Vtyp, thepressure support is computed as:A=G∫(Vent−Vtgt)dt  (2)

where G is the gain of the PI control. Larger values of gain G canresult in positive feedback in the therapy engine module 4320. Smallervalues of gain G may permit some residual untreated CSR or central sleepapnea. In some implementations, the gain G is fixed at a predeterminedvalue, such as −0.4 cmH₂O/(L/min)/sec. Alternatively, the gain G may bevaried between therapy sessions, starting small and increasing fromsession to session until a value that all but eliminates CSR is reached.Conventional means for retrospectively analysing the parameters of atherapy session to assess the severity of CSR during the therapy sessionmay be employed in such implementations. In yet other implementations,the gain G may vary depending on the difference between the currentmeasure Vent of ventilation and the target ventilation Vtgt.

Other servo-ventilation control methodologies that may be applied by thetherapy parameter determination algorithm 4329 include proportional (P),proportional-differential (PD), and proportional-integral-differential(PID).

The value of the pressure support A computed via equation (2) may beclipped to a range defined as [Amin, Amax]. In this implementation, thepressure support A sits by default at the minimum pressure support Aminuntil the measure of current ventilation Vent falls below the targetventilation Vtgt, at which point A starts increasing, only falling backto Amin when Vent exceeds Vtgt once again.

The pressure support limits Amin and Amax are settings of the RPT device4000, set for example by hard-coding during configuration of the RPTdevice 4000 or by manual entry through the input device 4220. A minimumpressure support Amin of 3 cmH₂O is of the order of 50% of the pressuresupport required to perform all the work of breathing of a typicalpatient in the steady state. A maximum pressure support Amax of 12 cmH₂Ois approximately double the pressure support required to perform all thework of breathing of a typical patient, and therefore sufficient tosupport the patient's breathing if they cease making any efforts, butless than a value that would be uncomfortable or dangerous.

In pressure support ventilation therapy modes, the EPAP is the basepressure P₀. As with the base pressure P₀ in CPAP therapy, the EPAP maybe a constant value that is prescribed or determined during titration.Such a constant EPAP may be set for example by hard-coding duringconfiguration of the RPT device 4000 or by manual entry through theinput device 4220. This alternative is sometimes referred to asfixed-EPAP pressure support ventilation therapy. Titration of the EPAPfor a given patient may be performed by a clinician during a titrationsession with the aid of PSG, with the aim of preventing obstructiveapneas, thereby maintaining an open airway for the pressure supportventilation therapy, in similar fashion to titration of the basepressure P₀ in constant CPAP therapy.

Alternatively, the therapy parameter determination algorithm 4329 maycontinuously compute the base pressure P₀ during pressure supportventilation therapy. In such implementations, the therapy parameterdetermination algorithm 4329 continuously computes the EPAP as afunction of indices or measures of sleep disordered breathing returnedby the respective algorithms in the therapy engine module 4320, such asone or more of flow limitation, apnea, hypopnea, patency, and snore.Because the continuous computation of the EPAP resembles the manualadjustment of the EPAP by a clinician during titration of the EPAP, thisprocess is also sometimes referred to as auto-titration of the EPAP, andthe overall therapy is known as auto-titrating EPAP pressure supportventilation therapy, or auto-EPAP pressure support ventilation therapy.

5.8 Glossary

For the purposes of the present technology disclosure, in certain formsof the present technology, one or more of the following definitions mayapply. In other forms of the present technology, alternative definitionsmay apply.

5.8.1 General

Air: In certain forms of the present technology, air may be taken tomean atmospheric air, and in other forms of the present technology airmay be taken to mean some other combination of breathable gases, e.g.atmospheric air enriched with oxygen.

Ambient: In certain forms of the present technology, the term ambientwill be taken to mean (i) external of the treatment system or patient,and (ii) immediately surrounding the treatment system or patient.

For example, ambient humidity with respect to a humidifier may be thehumidity of air immediately surrounding the humidifier, e.g. thehumidity in the room where a patient is sleeping. Such ambient humiditymay be different to the humidity outside the room where a patient issleeping.

In another example, ambient pressure may be the pressure immediatelysurrounding or external to the body.

In certain forms, ambient (e.g., acoustic) noise may be considered to bethe background noise level in the room where a patient is located, otherthan for example, noise generated by an RPT device or emanating from amask or patient interface. Ambient noise may be generated by sourcesoutside the room.

Respiratory Pressure Therapy (RPT): The application of a supply of airto an entrance to the airways at a treatment pressure that is typicallypositive with respect to atmosphere.

Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressuretherapy in which the treatment pressure is approximately constantthrough a respiratory cycle of a patient. In some forms, the pressure atthe entrance to the airways will be slightly higher during exhalation,and slightly lower during inhalation. In some forms, the pressure willvary between different respiratory cycles of the patient, for example,being increased in response to detection of indications of partial upperairway obstruction, and decreased in the absence of indications ofpartial upper airway obstruction.

Patient: A person, whether or not they are suffering from a respiratorydisease.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in whichthe treatment pressure is automatically adjustable, e.g. from breath tobreath, between minimum and maximum limits, depending on the presence orabsence of indications of SDB events.

5.8.2 Aspects of the Respiratory Cycle

Apnea: According to some definitions, an apnea is said to have occurredwhen flow falls below a predetermined threshold for a duration, e.g. 10seconds. An obstructive apnea will be said to have occurred when,despite patient effort, some obstruction of the airway does not allowair to flow. A central apnea will be said to have occurred when an apneais detected that is due to a reduction in breathing effort, or theabsence of breathing effort, despite the airway being patent. A mixedapnea occurs when a reduction or absence of breathing effort coincideswith an obstructed airway.

Breathing rate: The rate of spontaneous respiration of a patient,usually measured in breaths per minute.

Duty cycle: The ratio of inhalation time, Ti to total breath time, Ttot.

Effort (breathing): Breathing effort will be said to be the work done bya spontaneously breathing person attempting to breathe.

Expiratory portion of a breathing cycle: The period from the start ofexpiratory flow to the start of inspiratory flow.

Flow limitation: Flow limitation will be taken to be the state ofaffairs in a patient's respiration where an increase in effort by thepatient does not give rise to a corresponding increase in flow. Whereflow limitation occurs during an inspiratory portion of the breathingcycle it may be described as inspiratory flow limitation. Where flowlimitation occurs during an expiratory portion of the breathing cycle itmay be described as expiratory flow limitation.

Types of flow limited inspiratory waveforms:

(i) Flattened: Having a rise followed by a relatively flat portion,followed by a fall.

(ii) M-shaped: Having two local peaks, one at the leading edge, and oneat the trailing edge, and a relatively flat portion between the twopeaks.

(iii) Chair-shaped: Having a single local peak, the peak being at theleading edge, followed by a relatively flat portion.

(iv) Reverse-chair shaped: Having a relatively flat portion followed bysingle local peak, the peak being at the trailing edge.

Hypopnea: Preferably, a hypopnea will be taken to be a reduction inflow, but not a cessation of flow. In one form, a hypopnea may be saidto have occurred when there is a reduction in flow below a thresholdrate for a duration. A central hypopnea will be said to have occurredwhen a hypopnea is detected that is due to a reduction in breathingeffort. In one form in adults, either of the following may be regardedas being hypopneas:

-   -   (i) a 30% reduction in patient breathing for at least 10 seconds        plus an associated 4% desaturation; or    -   (ii) a reduction in patient breathing (but less than 50%) for at        least 10 seconds, with an associated desaturation of at least 3%        or an arousal.

Hyperpnea: An increase in flow to a level higher than normal flow rate.

Inspiratory portion of a breathing cycle: The period from the start ofinspiratory flow to the start of expiratory flow will be taken to be theinspiratory portion of a breathing cycle.

Patency (airway): The degree of the airway being open, or the extent towhich the airway is open. A patent airway is open. Airway patency may bequantified, for example with a value of one (1) being patent, and avalue of zero (0), being closed (obstructed).

Positive End-Expiratory Pressure (PEEP): The pressure above atmospherein the lungs that exists at the end of expiration.

Peak flow rate (Qpeak): The maximum value of flow rate during theinspiratory portion of the respiratory flow waveform.

Respiratory flow rate, airflow rate, patient airflow rate, respiratoryairflow rate (Qr): These synonymous terms may be understood to refer tothe RPT device's estimate of respiratory airflow rate, as opposed to“true respiratory flow” or “true respiratory airflow”, which is theactual respiratory flow rate experienced by the patient, usuallyexpressed in litres per minute.

Tidal volume (Vt): The volume of air inhaled or exhaled during normalbreathing, when extra effort is not applied.

(inhalation) Time (Ti): The duration of the inspiratory portion of therespiratory flow rate waveform.

(exhalation) Time (Te): The duration of the expiratory portion of therespiratory flow rate waveform.

(total) Time (Ttot): The total duration between the start of theinspiratory portion of one respiratory flow rate waveform and the startof the inspiratory portion of the following respiratory flow ratewaveform.

Typical recent ventilation: The value of ventilation around which recentvalues over some predetermined timescale tend to cluster, that is, ameasure of the central tendency of the recent values of ventilation.

Upper airway obstruction (UAO): includes both partial and total upperairway obstruction. This may be associated with a state of flowlimitation, in which the level of flow increases only slightly or mayeven decrease as the pressure difference across the upper airwayincreases (Starling resistor behaviour).

Ventilation (Vent): A measure of the total amount of gas being exchangedby the patient's respiratory system. Measures of ventilation may includeone or both of inspiratory and expiratory flow, per unit time. Whenexpressed as a volume per minute, this quantity is often referred to as“minute ventilation”. Minute ventilation is sometimes given simply as avolume, understood to be the volume per minute.

5.8.3 RPT Device Parameters

Flow rate: The instantaneous volume (or mass) of air delivered per unittime. While flow rate and ventilation have the same dimensions of volumeor mass per unit time, flow rate is measured over a much shorter periodof time. In some cases, a reference to flow rate will be a reference toa scalar quantity, namely a quantity having magnitude only. In othercases, a reference to flow rate will be a reference to a vectorquantity, namely a quantity having both magnitude and direction. Whereit is referred to as a signed quantity, a flow rate may be nominallypositive for the inspiratory portion of a breathing cycle of a patient,and hence negative for the expiratory portion of the breathing cycle ofa patient. Flow rate will be given the symbol Q. ‘Flow rate’ issometimes shortened to simply ‘flow’. Total flow rate, Qt, is the flowrate of air leaving the RPT device. Vent flow rate, Qv, is the flow rateof air leaving a vent to allow washout of exhaled gases. Leak flow rate,Ql, is the flow rate of leak from a patient interface system.Respiratory flow rate, Qr, is the flow rate of air that is received intothe patient's respiratory system.

Leak: The word leak will be taken to be an unintended flow of air. Inone example, leak may occur as the result of an incomplete seal betweena mask and a patient's face. In another example leak may occur in aswivel elbow to the ambient.

Noise, conducted (acoustic): Conducted noise in the present documentrefers to noise which is carried to the patient by the pneumatic path,such as the air circuit and the patient interface as well as the airtherein. In one form, conducted noise may be quantified by measuringsound pressure levels at the end of an air circuit.

Noise, radiated (acoustic): Radiated noise in the present documentrefers to noise which is carried to the patient by the ambient air. Inone form, radiated noise may be quantified by measuring soundpower/pressure levels of the object in question according to ISO 3744.

Noise, vent (acoustic): Vent noise in the present document refers tonoise which is generated by the flow of air through any vents such asvent holes in the patient interface.

Pressure: Force per unit area. Pressure may be measured in a range ofunits, including cmH₂O, g-f/cm², hectopascal. 1 cmH₂O is equal to 1g-f/cm² and is approximately 0.98 hectopascal. In this specification,unless otherwise stated, pressure is given in units of cmH₂O. Thepressure in the patient interface is given the symbol Pm, while thetreatment pressure, which represents a target value to be achieved bythe mask pressure Pm at the current instant of time, is given the symbolPt.

Sound Power: The energy per unit time carried by a sound wave. The soundpower is proportional to the square of sound pressure multiplied by thearea of the wavefront. Sound power is usually given in decibels SWL,that is, decibels relative to a reference power, normally taken as 10⁻¹²watt.

Sound Pressure: The local deviation from ambient pressure at a giventime instant as a result of a sound wave travelling through a medium.Sound pressure is usually given in decibels SPL, that is, decibelsrelative to a reference pressure, normally taken as 20×10⁻⁶ Pascal (Pa),considered the threshold of human hearing.

5.8.4 Terms for Ventilators

Adaptive Servo-Ventilator (ASV): A servo-ventilator that has achangeable, rather than fixed target ventilation. The changeable targetventilation may be learned from some characteristic of the patient, forexample, a respiratory characteristic of the patient.

Backup rate: A parameter of a ventilator that establishes the minimumbreathing rate (typically in number of breaths per minute) that theventilator will deliver to the patient, if not triggered by spontaneousrespiratory effort.

Cycled: The termination of a ventilator's inspiratory phase. When aventilator delivers a breath to a spontaneously breathing patient, atthe end of the inspiratory portion of the breathing cycle, theventilator is said to be cycled to stop delivering the breath.

Expiratory positive airway pressure (EPAP): a base pressure, to which apressure varying within the breath is added to produce the desired maskpressure which the ventilator will attempt to achieve at a given time.

End expiratory pressure (EEP): Desired mask pressure which theventilator will attempt to achieve at the end of the expiratory portionof the breath. If the pressure waveform template Π(Φ) is zero-valued atthe end of expiration, i.e. Π(Φ)=0 when Φ=1, the EEP is equal to theEPAP.

Inspiratory positive airway pressure (IPAP): Maximum desired maskpressure which the ventilator will attempt to achieve during theinspiratory portion of the breath.

Pressure support: A number that is indicative of the increase inpressure during ventilator inspiration over that during ventilatorexpiration, and generally means the difference in pressure between themaximum value during inspiration and the base pressure (e.g.,PS=IPAP−EPAP). In some contexts pressure support means the differencewhich the ventilator aims to achieve, rather than what it actuallyachieves.

Servo-ventilator: A ventilator that measures patient ventilation, has atarget ventilation, and which adjusts the level of pressure support tobring the patient ventilation towards the target ventilation.

Spontaneous/Timed (S/T): A mode of a ventilator or other device thatattempts to detect the initiation of a breath of a spontaneouslybreathing patient. If however, the device is unable to detect a breathwithin a predetermined period of time, the device will automaticallyinitiate delivery of the breath.

Swing: Equivalent term to pressure support.

Triggered: When a ventilator delivers a breath of air to a spontaneouslybreathing patient, it is said to be triggered to do so at the initiationof the respiratory portion of the breathing cycle by the patient'sefforts.

Typical recent ventilation: The typical recent ventilation Vtyp is thevalue around which recent measures of ventilation over somepredetermined timescale tend to cluster. For example, a measure of thecentral tendency of the measures of ventilation over recent history maybe a suitable value of a typical recent ventilation.

Ventilator: A mechanical device that provides pressure support to apatient to perform some or all of the work of breathing.

5.8.5 Anatomy of the Face

Ala: the external outer wall or “wing” of each nostril (plural: alar)

Alare: The most lateral point on the nasal ala.

Alar curvature (or alar crest) point: The most posterior point in thecurved base line of each ala, found in the crease formed by the union ofthe ala with the cheek.

Auricle: The whole external visible part of the ear.

(nose) Bony framework: The bony framework of the nose comprises thenasal bones, the frontal process of the maxillae and the nasal part ofthe frontal bone.

(nose) Cartilaginous framework: The cartilaginous framework of the nosecomprises the septal, lateral, major and minor cartilages.

Columella: the strip of skin that separates the nares and which runsfrom the pronasale to the upper lip.

Columella angle: The angle between the line drawn through the midpointof the nostril aperture and a line drawn perpendicular to the Frankfurthorizontal while intersecting subnasale.

Frankfort horizontal plane: A line extending from the most inferiorpoint of the orbital margin to the left tragion. The tragion is thedeepest point in the notch superior to the tragus of the auricle.

Glabella: Located on the soft tissue, the most prominent point in themidsagittal plane of the forehead.

Lateral nasal cartilage: A generally triangular plate of cartilage. Itssuperior margin is attached to the nasal bone and frontal process of themaxilla, and its inferior margin is connected to the greater alarcartilage.

Greater alar cartilage: A plate of cartilage lying below the lateralnasal cartilage. It is curved around the anterior part of the naris. Itsposterior end is connected to the frontal process of the maxilla by atough fibrous membrane containing three or four minor cartilages of theala.

Nares (Nostrils): Approximately ellipsoidal apertures forming theentrance to the nasal cavity. The singular form of nares is naris(nostril). The nares are separated by the nasal septum.

Naso-labial sulcus or Naso-labial fold: The skin fold or groove thatruns from each side of the nose to the corners of the mouth, separatingthe cheeks from the upper lip.

Naso-labial angle: The angle between the columella and the upper lip,while intersecting subnasale.

Otobasion inferior: The lowest point of attachment of the auricle to theskin of the face.

Otobasion superior: The highest point of attachment of the auricle tothe skin of the face.

Pronasale: the most protruded point or tip of the nose, which can beidentified in lateral view of the rest of the portion of the head.

Philtrum: the midline groove that runs from lower border of the nasalseptum to the top of the lip in the upper lip region.

Pogonion: Located on the soft tissue, the most anterior midpoint of thechin.

Ridge (nasal): The nasal ridge is the midline prominence of the nose,extending from the Sellion to the Pronasale.

Sagittal plane: A vertical plane that passes from anterior (front) toposterior (rear) dividing the body into right and left halves.

Sellion: Located on the soft tissue, the most concave point overlyingthe area of the frontonasal suture.

Septal cartilage (nasal): The nasal septal cartilage forms part of theseptum and divides the front part of the nasal cavity.

Subalare: The point at the lower margin of the alar base, where the alarbase joins with the skin of the superior (upper) lip.

Subnasal point: Located on the soft tissue, the point at which thecolumella merges with the upper lip in the midsagittal plane.

Supramentale: The point of greatest concavity in the midline of thelower lip between labrale inferius and soft tissue pogonion

5.8.6 Anatomy of the Skull

Frontal bone: The frontal bone includes a large vertical portion, thesquama frontalis, corresponding to the region known as the forehead.

Mandible: The mandible forms the lower jaw. The mental protuberance isthe bony protuberance of the jaw that forms the chin.

Maxilla: The maxilla forms the upper jaw and is located above themandible and below the orbits. The frontal process of the maxillaprojects upwards by the side of the nose, and forms part of its lateralboundary.

Nasal bones: The nasal bones are two small oblong bones, varying in sizeand form in different individuals; they are placed side by side at themiddle and upper part of the face, and form, by their junction, the“bridge” of the nose.

Nasion: The intersection of the frontal bone and the two nasal bones, adepressed area directly between the eyes and superior to the bridge ofthe nose.

Occipital bone: The occipital bone is situated at the back and lowerpart of the cranium. It includes an oval aperture, the foramen magnum,through which the cranial cavity communicates with the vertebral canal.The curved plate behind the foramen magnum is the squama occipitalis.

Orbit: The bony cavity in the skull to contain the eyeball.

Parietal bones: The parietal bones are the bones that, when joinedtogether, form the roof and sides of the cranium.

Temporal bones: The temporal bones are situated on the bases and sidesof the skull, and support that part of the face known as the temple.

Zygomatic bones: The face includes two zygomatic bones, located in theupper and lateral parts of the face and forming the prominence of thecheek.

5.8.7 Anatomy of the Respiratory System

Diaphragm: A sheet of muscle that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, containing the heart,lungs and ribs, from the abdominal cavity. As the diaphragm contractsthe volume of the thoracic cavity increases and air is drawn into thelungs.

Larynx: The larynx, or voice box houses the vocal folds and connects theinferior part of the pharynx (hypopharynx) with the trachea.

Lungs: The organs of respiration in humans. The conducting zone of thelungs contains the trachea, the bronchi, the bronchioles, and theterminal bronchioles. The respiratory zone contains the respiratorybronchioles, the alveolar ducts, and the alveoli.

Nasal cavity: The nasal cavity (or nasal fossa) is a large air filledspace above and behind the nose in the middle of the face. The nasalcavity is divided in two by a vertical fin called the nasal septum. Onthe sides of the nasal cavity are three horizontal outgrowths callednasal conchae (singular “concha”) or turbinates. To the front of thenasal cavity is the nose, while the back blends, via the choanae, intothe nasopharynx.

Pharynx: The part of the throat situated immediately inferior to (below)the nasal cavity, and superior to the oesophagus and larynx. The pharynxis conventionally divided into three sections: the nasopharynx(epipharynx) (the nasal part of the pharynx), the oropharynx(mesopharynx) (the oral part of the pharynx), and the laryngopharynx(hypopharynx).

5.8.8 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, an exemplary form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240.

Polycarbonate: a typically transparent thermoplastic polymer ofBisphenol-A Carbonate.

5.8.9 Aspects of a Patient Interface

Anti-asphyxia valve (AAV): The component or sub-assembly of a masksystem that, by opening to atmosphere in a failsafe manner, reduces therisk of excessive CO₂ rebreathing by a patient.

Elbow: A conduit that directs an axis of flow of air to change directionthrough an angle. In one form, the angle may be approximately 90degrees. In another form, the angle may be less than 90 degrees. Theconduit may have an approximately circular cross-section. In anotherform the conduit may have an oval or a rectangular cross-section.

Frame: Frame will be taken to mean a mask structure that bears the loadof tension between two or more points of connection with a headgear. Amask frame may be a non-airtight load bearing structure in the mask.However, some forms of mask frame may also be air-tight.

Headgear: Headgear will be taken to mean a form of positioning andstabilizing structure designed for use on a head. Preferably theheadgear comprises a collection of one or more struts, ties andstiffeners configured to locate and retain a patient interface inposition on a patient's face for delivery of respiratory therapy. Someties are formed of a soft, flexible, elastic material such as alaminated composite of foam and fabric.

Membrane: Membrane will be taken to mean a typically thin element thathas, preferably, substantially no resistance to bending, but hasresistance to being stretched.

Plenum chamber: a mask plenum chamber will be taken to mean a portion ofa patient interface having walls at least partially enclosing a volumeof space, the volume having air therein pressurised above atmosphericpressure in use. A shell may form part of the walls of a mask plenumchamber.

Seal: The noun form (“a seal”) will be taken to mean a structure orbarrier that intentionally resists the flow of air through the interfaceof two surfaces. The verb form (“to seal”) will be taken to mean toresist a flow of air.

Shell: A shell will be taken to mean a curved, relatively thin structurehaving bending, tensile and compressive stiffness. For example, a curvedstructural wall of a mask may be a shell. In some forms, a shell may befaceted. In some forms a shell may be airtight. In some forms a shellmay not be airtight.

Stiffener: A stiffener will be taken to mean a structural componentdesigned to increase the bending resistance of another component in atleast one direction.

Strut: A strut will be taken to be a structural component designed toincrease the compression resistance of another component in at least onedirection.

Swivel: (noun) A subassembly of components configured to rotate about acommon axis, preferably independently, preferably under low torque. Inone form, the swivel may be constructed to rotate through an angle of atleast 360 degrees. In another form, the swivel may be constructed torotate through an angle less than 360 degrees. When used in the contextof an air delivery conduit, the sub-assembly of components preferablycomprises a matched pair of cylindrical conduits. There may be little orno leak flow of air from the swivel in use.

Tie: A tie will be taken to be a structural component designed to resisttension.

Vent: (noun) the structure that allows a flow of air from an interior ofthe mask, or conduit, to ambient air to allow clinically effectivewashout of exhaled gases. For example, a clinically effective washoutmay involve a flow rate of about 10 litres per minute to about 100litres per minute, depending on the mask design and treatment pressure.

5.8.10 Terms Used in Relation to Patient Interface

Curvature (of a surface): A region of a surface having a saddle shape,which curves up in one direction and curves down in a differentdirection, will be said to have a negative curvature. A region of asurface having a dome shape, which curves the same way in two principaldirections, will be said to have a positive curvature. A flat surfacewill be taken to have zero curvature.

Floppy: A quality of a material, structure or composite that is one ormore of:

-   -   Readily conforming to finger pressure.    -   Unable to retain its shape when caused to support its own        weight.    -   Not rigid.    -   Able to be stretched or bent elastically with little effort.

The quality of being floppy may have an associated direction, hence aparticular material, structure or composite may be floppy in a firstdirection, but stiff or rigid in a second direction, for example asecond direction that is orthogonal to the first direction.

Resilient: Able to deform substantially elastically, and to releasesubstantially all of the energy upon unloading, within a relativelyshort period of time such as 1 second.

Rigid: Not readily deforming to finger pressure, and/or the tensions orloads typically encountered when setting up and maintaining a patientinterface in sealing relationship with an entrance to a patient'sairways.

Semi-rigid: means being sufficiently rigid to not substantially distortunder the effects of mechanical forces typically applied duringrespiratory pressure therapy.

5.8.11 Curvature

Products in accordance with the present technology may comprise one ormore real three-dimensional structures, for example a mask cushion or animpeller. The three-dimensional structures may be bounded bytwo-dimensional surfaces. These surfaces may be distinguished using alabel to describe an associated surface orientation, location, function,or some other characteristic. For example a structure may comprise oneor more of an anterior surface, a posterior surface, an interior surfaceand an exterior surface. In another example, a cushion structure maycomprise a face-contacting (e.g. outer) surface, and a separatenon-face-contacting (e.g. underside or inner) surface. In anotherexample, a structure may comprise a first surface and a second surface.

To facilitate describing the shape of the three-dimensional structuresand the surfaces, we first consider a cross-section through a surface ofthe structure at a point, p. See FIG. 3B to FIG. 3F, which illustrateexamples of cross-sections at point p on a surface, and the resultingplane curves. FIGS. 3B to 3F also illustrate an outward normal vector atp. The outward normal vector at p points away from the surface. In someexamples we describe the surface from the point of view of an imaginarysmall person standing upright on the surface.

5.8.11.1 Curvature in One Dimension

The curvature of a plane curve at p may be described as having a sign(e.g. positive, negative) and a magnitude (e.g. 1/radius of a circlethat just touches the curve at p).

Positive curvature: If the curve at p turns towards the outward normal,the curvature at that point will be taken to be positive (if theimaginary small person leaves the point p they must walk uphill). SeeFIG. 3B (relatively large positive curvature compared to FIG. 3C) andFIG. 3C (relatively small positive curvature compared to FIG. 3B). Suchcurves are often referred to as concave.

Zero curvature: If the curve at p is a straight line, the curvature willbe taken to be zero (if the imaginary small person leaves the point p,they can walk on a level, neither up nor down). See FIG. 3D.

Negative curvature: If the curve at p turns away from the outwardnormal, the curvature in that direction at that point will be taken tobe negative (if the imaginary small person leaves the point p they mustwalk downhill) See FIG. 3E (relatively small negative curvature comparedto FIG. 3F) and FIG. 3F (relatively large negative curvature compared toFIG. 3E). Such curves are often referred to as convex.

5.8.11.2 Curvature of Two Dimensional Surfaces

A description of the shape at a given point on a two-dimensional surfacein accordance with the present technology may include multiple normalcross-sections. The multiple cross-sections may cut the surface in aplane that includes the outward normal (a “normal plane”), and eachcross-section may be taken in a different direction. Each cross-sectionresults in a plane curve with a corresponding curvature. The differentcurvatures at that point may have the same sign, or a different sign.Each of the curvatures at that point has a magnitude, e.g. relativelysmall. The plane curves in FIGS. 3B to 3F could be examples of suchmultiple cross-sections at a particular point.

Principal curvatures and directions: The directions of the normal planeswhere the curvature of the curve takes its maximum and minimum valuesare called the principal directions. In the examples of FIG. 3B to FIG.3F, the maximum curvature occurs in FIG. 3B, and the minimum occurs inFIG. 3F, hence FIG. 3B and FIG. 3F are cross sections in the principaldirections. The principal curvatures at p are the curvatures in theprincipal directions.

Region of a surface: A set of points on a surface. The set of points ina region may have similar characteristics, e.g. curvatures or signs.

Saddle region: A region where at each point, the principal curvatureshave opposite signs, that is, one is positive, and the other is negative(depending on the direction to which the imaginary person turns, theymay walk uphill or downhill)

Dome region: A region where at each point the principal curvatures havethe same sign, e.g. both positive (a “concave dome”) or both negative (a“convex dome”).

Cylindrical region: A region where one principal curvature is zero (or,for example, zero within manufacturing tolerances) and the otherprincipal curvature is non-zero.

Planar region: A region of a surface where both of the principalcurvatures are zero (or, for example, zero within manufacturingtolerances).

Edge of a surface: A boundary or limit of a surface.

Path: In certain forms of the present technology, ‘path’ will be takento mean a path in the mathematical—topological sense, e.g. a continuousspace curve from f(0) to f(1) on a surface. In certain forms of thepresent technology, a ‘path’ may be described as a route or course,including e.g. a set of points on a surface. (The path for the imaginaryperson is where they walk on the surface, and is analogous to a gardenpath).

Path length: In certain forms of the present technology, ‘path length’will be taken to the distance along the surface from f(0) to f(1), thatis, the distance along the path on the surface. There may be more thanone path between two points on a surface and such paths may havedifferent path lengths. (The path length for the imaginary person wouldbe the distance they have to walk on the surface along the path).

Straight-line distance: The straight-line distance is the distancebetween two points on a surface, but without regard to the surface. Onplanar regions, there would be a path on the surface having the samepath length as the straight-line distance between two points on thesurface. On non-planar surfaces, there may be no paths having the samepath length as the straight-line distance between two points. (For theimaginary person, the straight-line distance would correspond to thedistance ‘as the crow flies’.)

5.9 Other Remarks

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct acomponent, obvious alternative materials with similar properties may beused as a substitute. Furthermore, unless specified to the contrary, anyand all components herein described are understood to be capable ofbeing manufactured and, as such, may be manufactured together orseparately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by referencein their entirety to disclose and describe the methods and/or materialswhich are the subject of those publications. The publications discussedherein are provided solely for their disclosure prior to the filing dateof the present application. Nothing herein is to be construed as anadmission that the present technology is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dates,which may need to be independently confirmed.

The terms “comprises” and “comprising” should be interpreted asreferring to elements, components, or steps in a non-exclusive manner,indicating that the referenced elements, components, or steps may bepresent, or utilized, or combined with other elements, components, orsteps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative examples and that other arrangements may be devisedwithout departing from the spirit and scope of the technology.

Also, it should be appreciated that one or more aspects of the presenttechnology may be combinable with one or more aspects of: PCTApplication No. PCT/AU2016/050891, filed Sep. 23, 2016 and entitled“Patient Interface”, which claims the benefit of U.S. ProvisionalApplication No. 62/222,593, filed Sep. 23, 2015 and U.S. ProvisionalApplication No. 62/376,961, filed Aug. 19, 2016; U.S. ProvisionalApplication No. 62/377,217, filed Aug. 19, 2016 and entitled “PatientInterface with a Seal-Forming Structure having Varying Thickness”; U.S.Provisional Application No. 62/377,158, filed Aug. 19, 2016 and entitled“Patient Interface with a Seal-Forming Structure having VaryingThickness”; PCT Application No. PCT/AU2016/050892, filed Sep. 23, 2016and entitled “Elbow Assembly”, which claims the benefit of U.S.Provisional Application No. 62/222,435, filed Sep. 23, 2015 and U.S.Provisional Application No. 62/376,718, filed Aug. 18, 2016; U.S.Provisional Application No. 62/377,217, filed Aug. 19, 2016 and entitled“Patient Interface with a Seal-Forming Structure having VaryingThickness”; U.S. Provisional Application No. 62/377,158, filed Aug. 19,2016 and entitled “Patient Interface with a Seal-Forming Structurehaving Varying Thickness”; and/or PCT Application No. PCT/AU2016/050228filed Mar. 24, 2016 and entitled “Patient Interface with BlowoutPrevention for Seal-Forming Portion”, which claims the benefit of U.S.Provisional Application No. 62/138,009, filed Mar. 25, 2015 and U.S.Provisional Application No. 62/222,503, filed Sep. 23, 2015; each of theabove-noted applications of which is incorporated herein by reference inits entirety.

5.10 Reference Characters List

patient 1000 bed partner 1100 patient interface 3000 seal-formingstructure 3100 plenum chamber 3200 positioning and stabilising structure3300 rigidiser arm 3301 superior attachment point 3302 inferior strapconnector 3303 inferior attachment point 3304 shroud 3305 clip 3306hinge 3307 vent 3400 orifice 3402 wall 3404 diffusing member 3406blocking member 3408 channels 3410 hole 3412 central hole 3414 radialopening 3416 elbow 3418 wall 3420 cap 3422 annular flange 3424 annulargap 3426 annular groove 3428 annular protrusion 3430 lip 3432 ball 3434socket 3436 snap fit connection 3438 first half 3440 second half 3442decoupling structure 3500 connection port 3600 forehead support 3700 RPTdevice 4000 external housing 4010 upper portion 4012 lower portion 4014panel 4015 chassis 4016 handle 4018 pneumatic block 4020 mechanical andpneumatic components 4100 air filter 4110 inlet air filter 4112 outletair filter 4114 muffler 4120 inlet muffler 4122 outlet muffler 4124pressure generator 4140 blower 4142 motor 4144 anti-spill back valve4160 air circuit 4170 heated air circuit 4171 tube 4172 RPT deviceconnector 4173 vent adaptor connector 4174 bayonet connector 4175 griprecess 4176 seal 4177 tube connector 4178 supplemental oxygen 4180electrical components 4200 printed circuit board assembly (PCBA) 4202power supply 4210 input device 4220 central controller 4230 therapydevice controller 4240 protection circuits 4250 memory 4260 transducer4270 data communication interface 4280 output device 4290 algorithms4300 pre-processing module 4310 pressure compensation algorithm 4312vent flow rate estimation algorithm 4314 leak flow rate estimationalgorithm 4316 respiratory flow rate estimation algorithm 4318 therapyengine module 4320 fuzzy phase determination algorithm 4321 waveformdetermination algorithm 4322 ventilation determination algorithm 4323inspiratory flow limitation determination algorithm 4324 apnea/hypopneadetermination algorithm 4325 snore determination algorithm 4326 airwaypatency determination algorithm 4327 target ventilation determinationalgorithm 4328 therapy parameter determination algorithm 4329 therapycontrol module 4330 fault condition detection 4340 therapy device 4350humidifier 5000 humidifier inlet 5002 humidifier outlet 5004 humidifierbase 5006 humidifier reservoir 5110 conductive portion 5120 humidifierreservoir dock 5130 locking lever 5135 water level indicator 5150humidifier transducer 5210 pressure transducer 5212 air flow ratetransducer 5214 temperature transducer 5216 humidity sensor 5218 heatingelement 5240 humidifier controller 5250 central humidifier controller5251 heating element controller 5252 air circuit controller 5254 HME7000 layer 7001 corrugated structure 7002 top structure 7010 superiorchannel 7012 base structure 7020 inferior channel 7022 corrugation 7030upper folded portion 7031 fluid connector 9000 first end 9002 second end9004 fluid conduit 9006 seal portion 9008 first opening 9010 latchingportion 9012 complementary latching portion 9014 sealing surface 9016second opening 9018 second tube 9020 first tube 9022 inner portion 9024outer portion 9026 interface 9028 stop 9030 port 9032 overhang portion9034 pressure tap 9036 guide portion 9038 vent adaptor 9100 conduitconnector 9110 conduit end 9111 vent adaptor end 9112 anti-asphyxiavalve (AAV) openings 9113 ring 9115 air circuit connector 9116 bayonetconnector 9117 vent housing 9120 end 9121 protrusions 9122 tab 9123 lip9124 external vent hole 9125 internal vent hole 9126 shoulder 9127support 9128 notches 9129 vent diffuser cover 9130 anti-asphyxia valve(AAV) 9135 flap 9140 flap retaining structure 9141 HME material 9145diffuser 9146 diffuser opening 9147 diffuser retaining ring 9148 radialdiffuser retainer 9149 CFV ring 9150 vent housing connector 9160 firstbar 9161 second bar 9162 receptacle 9163 notch 9164 curved outer surface9165 bayonet connector 9166 HME clip 9170 arm 9171 central shaft 9172shaft end 9173 arm ends 9174 HME housing 9180 slots 9181 cross-member9182 receiver 9183 outer wall 9184 cut-outs 9185 bellows seal 9190bellows seal connector 9191 outer surface 9192 inner surface 9193shoulder surface 9194 vent adaptor connector 9200 orifice 9201 rim 9202rim 9203 short tube assembly 9210 tube 9212 tube-housing connector 9214tube-elbow connector 9216 elbow assembly 9220 elbow frame 9222 elbowovermould 9224 vent core structure 9300 inlet 9301 air circuit connector9302 clip 9304 vent core extension 9306 outer orifices 9308 innerorifices 9310 alignment structure 9312 vent housing 9320 bayonetconnector 9322 membrane retainer 9324 vent diffuser cover 9330 coverspacers 9332 connection surface 9334 posterior vent outlet 9340 anteriorvent outlet 9342 HME housing 9400 patient-side HME housing portion 9402atmosphere-side HME housing portion 9404 patient-side HME housingportion cross-bar 9406 atmosphere-side HME housing portion cross-bar9408 opening 9410 tab 9412 atmosphere-side HME housing portion ring 9414HME inner housing 9416 HME bypass passage 9418 lip seal 9500 baffle 9600plenum chamber connector 9700 nasal cushion patient interface 3000Anasal pillows patient interface 3000B full face patient interface 3000Cvent system 13400 vent housing 13401 outer wall 13402 outer base 13403outer orifice 13404 lateral membrane support 13405 inner base 13406inner orifice 13407 base connector 13408 membrane spacer 13409 innerwall 13410 inlet 13411 membrane spacer gap 13412 inner base slot 13413recess divider 13414 recess 13415 membrane 13430 membrane opening 13431patient-side surface 13432 atmosphere-side surface 13433 inner surface13434 outer surface 13435

The invention claimed is:
 1. A system for delivery of pressurized air toa patient to treat a sleep-related breathing disorder, the systemcomprising: a respiratory pressure therapy device including: a blowerconfigured to pressurize a flow of air to a treatment pressure; anoutlet opening configured to direct the flow of air at the treatmentpressure out of the respiratory pressure therapy device; a seal portionsurrounding the outlet opening and having a bellows shape or a partialbellows shape; and a first latching portion; and an air circuitcomprising: a fluid conduit having a first end and a second end; a fluidconduit connector connected to the first end of the fluid conduit,configured to removably connect to the respiratory pressure therapydevice, and including: an inlet opening configured to receive the flowof air at the treatment pressure from the outlet opening; a sealingsurface surrounding the inlet opening and configured to engage the sealportion to form a face seal to seal the flow of air at the treatmentpressure traveling from the respiratory pressure therapy device to thefluid conduit when the fluid conduit connector is removably connected torespiratory pressure therapy device; and a second latching portionconfigured to engage with the first latching portion to removablyconnect the respiratory pressure therapy device to the fluid conduitconnector; and a vent adaptor connected to the second end of the fluidconduit, configured to removably connect to a patient interface worn bythe patient during treatment to direct the flow of air at the treatmentpressure from the respiratory pressure therapy device to the patient,and comprising a plurality of vent holes.
 2. The system of claim 1,wherein the sealing surface is flat.
 3. The system of claim 2, whereinthe sealing surface is oriented substantially perpendicular to adirection of the flow of air at the treatment pressure traveling fromthe respiratory pressure therapy device to the air circuit.
 4. Thesystem of claim 1, wherein the sealing surface is bevelled.
 5. Thesystem of claim 1, wherein the fluid conduit connector includes a tubethat forms the inlet opening and the sealing surface is formed on aflange that extends radially from the tube at the inlet opening.
 6. Thesystem according to claim 5, wherein the flange extends substantiallyperpendicularly to a longitudinal axis of the tube.
 7. The systemaccording to claim 5, wherein the flange is recessed from an end of thetube.
 8. The system according to claim 7, wherein the tube is configuredto extend at least partially into the seal portion when the firstlatching portion is engaged with the second latching portion.
 9. Thesystem of claim 1, wherein the seal portion is compliant in a directionof engagement between the respiratory pressure therapy device and thefluid conduit connector.
 10. The system of claim 1, wherein the sealportion includes a frustoconical portion.
 11. The system of claim 10,wherein the frustoconical portion is configured to contact the sealingsurface to form the face seal when the respiratory pressure therapydevice and the fluid conduit connector are removably connected.
 12. Thesystem of claim 1, wherein the seal portion includes a partiallyspherical surface.
 13. The system of claim 12, wherein the partiallyspherical surface is configured to contact the sealing surface to formthe face seal when the respiratory pressure therapy device and the fluidconduit connector are removably connected.
 14. The system of claim 1,wherein the seal portion is configured to engage the sealing surfacebefore the first latching portion and the second latching portionengage, when the respiratory pressure therapy device and the fluidconduit connector are removably connected.
 15. The system of claim 1,wherein the seal portion is configured such that a force required tocompress the seal portion is less than a force required to engage thefirst latching portion with the second latching portion.
 16. The systemof claim 1, wherein the fluid conduit connector comprises an innerportion and an outer portion, the inner portion being rotatably coupledto the outer portion.
 17. The system of claim 16, wherein the sealingsurface is formed on the inner portion.
 18. The system of claim 17,wherein the inner portion is rigidly connected to the fluid conduit. 19.The system of claim 16, wherein the second latching portion is formed onthe outer portion.
 20. The system of claim 1, wherein the secondlatching portion comprises a cantilevered portion with a protrusion thatis configured to engage the first latching portion, and wherein thecantilevered portion is configured to be depressed to engage ordisengage the second latching portion from the first latching portionand allow engagement or disengagement between the respiratory pressuretherapy device and the fluid conduit connector.
 21. The system of claim1, wherein the respiratory pressure therapy device comprises a flangearound the outlet opening and the fluid conduit connector comprises astop surface configured to contact the flange to constrain the fluidconduit connector from moving in a direction of engagement between therespiratory pressure therapy device and the fluid conduit connector. 22.The system of claim 1, wherein the respiratory pressure therapy deviceforms a female connection and the fluid conduit connector forms a maleconnection.
 23. The system of claim 1, wherein the respiratory pressuretherapy device includes a port in fluid communication with an interiorof the seal portion.
 24. The system of claim 1, wherein the vent adaptorcomprises an elbow connected to the second end of the fluid conduit. 25.The system of claim 1, wherein the vent adaptor comprises a tubeconfigured to removably connect to a connection port of the patientinterface.